CompletedNCT00305682Updated Nov 19, 2020Results posted

Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant

A Phase 2 interventional study of anti-thymocyte globulin and cyclophosphamide in Myeloproliferative Disorders, Leukemia and Lymphoma, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by Masonic Cancer Center, University of Minnesota · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 9 months after the study started (first participant enrolled Jun 2005, registered Mar 2006).

Phase: Phase 2
Study type: Interventional
Enrollment: 295
Allocation: Non-randomized
Ages: Up to 75 Years
Sex: All

Study summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. An umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving sirolimus and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by an umbilical cord blood transplant, sirolimus, and mycophenolate mofetil works in treating patients with hematologic cancer.

Read the detailed description

OBJECTIVES:

Primary

Determine the one- and two-year survival of patients with hematologic malignancies treated with a nonmyeloablative conditioning regimen comprising fludarabine, cyclophosphamide, and total-body irradiation followed by umbilical cord blood transplantation and post-transplant immunosuppression comprising sirolimus and mycophenolate mofetil.

Secondary

Determine the six-month nonrelapse mortality of patients treated with this regimen.
Determine the presence of chimerism in patients treated with this regimen at days 21, 60, 100, 180, and 365.
Determine the incidence of neutrophil engraftment by day 42 in patients treated with this regimen.
Determine the incidence of platelet engraftment by six months in patients treated with this regimen.
Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 in patients treated with this regimen.
Determine the incidence of chronic GVHD at one year in patients treated with this regimen.
Determine the probability of overall survival within one or two years in patients treated with this regimen.
Determine the probability of progression-free survival within one or two years in patients treated with this regimen.
Determine the incidence of relapse or disease progression within one or two years in patients treated with this regimen.

OUTLINE: This is a nonrandomized study. Patients are stratified into five disease groups: 1. acute myeloid leukemia, myelodysplastic syndromes, chronic myelogenous leukemia [CML] in first chronic phase and second chronic phase [CP2] after myeloid blast crisis; 2. acute lymphoblastic leukemia, Burkitt's lymphoma, CML CP2 post lymphoid blast crisis, 3. large-cell B and T-cell lymphoma, mantle cell lymphoma; 4. chronic lymphocytic leukemia/small lymphocytic lymphoma, prolymphocytic leukemia, marginal zone B-cell lymphoma, follicular lymphoma; 5. Hodgkin's lymphoma and multiple myeloma.

Nonmyeloablative conditioning: Patients receive fludarabine intravenously on days -6 to -2 and cyclophosphamide IV on day -6. Patients who did not undergo prior autologous transplant or who received ≤ 1 course of prior multiagent chemotherapy or no severely immunosuppressive therapy in the past 3 months also receive anti-thymocyte globulin IV on days -6 to -4. All patients also undergo total-body irradiation on day -1.
Umbilical cord blood transplant: Patients undergo umbilical cord blood transplantation on day 0.
Post-transplant immunosuppression: Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation. Patients also receive mycophenolate mofetil IV on days -3 to 5 and then orally on days 6-30.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.

Conditions studied

Myeloproliferative Disorders
Leukemia
Lymphoma
Myelodysplastic Syndromes

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In context

Myelodysplastic Syndromes

2,124 studies on the registry are indexed under Myelodysplastic Syndromes; 320 are open to participants now.

This study's enrollment of 295 is above the median of 39 across 1,740 interventional studies indexed under Myelodysplastic Syndromes.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age, Graft Cell Dose and Graft HLA Criteria

Subjects must be \<70 years old. Subjects ages ≥ 70 and ≤ 75 may be eligible if they have a Co-Morbidity Scoring (HCT-CI) score ≤ 2.
The UCB graft is matched at 4-6 HLA-A, B, DRB1 antigens with the recipient.
Patients co-enrolled in MT-2006-01 Phase I Study of Infusion of Umbilical Cord Blood Derived CD25+CD4+ T-Regulatory (Treg) Cells after Non-Myeloablative Cord\Blood Transplantation will receive grafts composed of 2 UCB units.

Disease Criteria:

Acute Leukemias:
- Acute myeloid leukemia: high risk complete remission 1 (CR1) (as evidenced by preceding myelodysplastic syndrome (MDS), high risk cytogenetics such as those associated with MDS or complex karyotype, > 2 cycles to obtain CR or erythroblastic and megakaryocytic); second or greater CR.
- Acute lymphoblastic leukemia/lymphoma: high risk CR1 as evidenced by high risk cytogenetics (e.g. t(9;22), t(1;19),t(4;11), other myeloid/lymphoid or mixed lineage leukemia [MLL] rearrangements, hypodiploidy or Ikaros family zinc finger 1 [IKZF1]), > 1 cycle to obtain CR or evidence of minimal residual disease (MRD). Patients in second or greater CR are also eligible.
Burkitt's lymphoma in CR2 or subsequent CR
Natural Killer cell malignancies
Chronic myelogenous leukemia: all types except refractory blast crisis. Chronic phase patients must have failed or been intolerant to Gleevec
Myelodysplastic syndrome:
Large-cell lymphoma, Hodgkin lymphoma and multiple myeloma with chemotherapy sensitive disease that has failed or patients who are ineligible for an autologous transplant.
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma, which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for debulking chemotherapy before transplant. Patients with refractory disease are eligible, unless has bulky disease and an estimated tumor doubling time of less than one month.
Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy if chemotherapy sensitive.
Refractory leukemia or MDS.
Bone marrow failure syndromes, except for Fanconi Anemia
Myeloproliferative syndromes Patients who have undergone an autologous transplant >12 months prior to allogeneic transplantation

Adequate Organ Function and Performance Status

Exclusion criteria

Exclusion Criteria:

\< 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
Pregnancy or breastfeeding
Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology
Current active serious infection
Unless in post-chemotherapy and radioimmunoconjugated antibody induced aplasia, when he/she would be eligible for Arm 3, patients with acute leukemia in morphologic relapse/ persistent disease defined as > 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods) or associated cytogenetic markers that allows morphologic relapse to be distinguished are not eligible.
Chronic myelogenous leukemia (CML) in refractory blast crisis
Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.
Active central nervous system malignancy

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 295 participants (actual)

Study arms

Active comparator
Arm 1-Previous Autologous Transplant
Arm 1 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
Drug: cyclophosphamide · Drug: Fludarabine · Drug: mycophenolate mofetil · Procedure: umbilical cord blood transplantation · Radiation: total body irradiation · Drug: Sirolimus
Active comparator
Arm 2 - No Prior Autologous Transplant
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
Biological: anti-thymocyte globulin · Drug: cyclophosphamide · Drug: Fludarabine · Drug: mycophenolate mofetil · Procedure: umbilical cord blood transplantation · Radiation: total body irradiation · Drug: Sirolimus
Active comparator
Arm 3 - Refractory Leukemia/Lymphoma
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
Biological: anti-thymocyte globulin · Drug: cyclophosphamide · Drug: Fludarabine · Drug: mycophenolate mofetil · Procedure: umbilical cord blood transplantation · Radiation: total body irradiation · Drug: Sirolimus
Active comparator
Arm 4: MT2006-01 coenrolling patients
Arm 4 - hematologic malignancy patients enrolled in MT2006-01. Conditioning Fludarabine dose of 40 mg/m2/day x 5, cyclophosphamide and total body irradiation with or without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
Drug: cyclophosphamide · Drug: Fludarabine · Drug: mycophenolate mofetil · Procedure: umbilical cord blood transplantation · Radiation: total body irradiation · Drug: Sirolimus
Active comparator
Arm 5 - Previous Autologous Transplant
Arm 5 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT). Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation without anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
Drug: cyclophosphamide · Drug: Fludarabine · Drug: mycophenolate mofetil · Procedure: umbilical cord blood transplantation · Radiation: total body irradiation · Drug: Sirolimus
Active comparator
Arm 6 - No prior autologous transplant
Arm 6 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin as conditioning regimen. Conditioning Fludarabine dose of 30 mg/m2/day x 5, cyclophosphamide and total body irradiation with anti-thymocyte globulin followed by umbilical cord blood transplantation, and peri-transplant Mycophenolate Mofetil and Sirolimus.
Biological: anti-thymocyte globulin · Drug: cyclophosphamide · Drug: Fludarabine · Drug: mycophenolate mofetil · Procedure: umbilical cord blood transplantation · Radiation: total body irradiation · Drug: Sirolimus

Interventions

Biologicalanti-thymocyte globulin
Equine ATG dose is 15 mg/kg intravenously (IV) every 12 hours for 6 doses on days -6, - 5, and -4.
Also known as: ATGAM, ATG
Drugcyclophosphamide
Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
Also known as: Cytoxan
DrugFludarabine
Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
Also known as: Fludara
Drugmycophenolate mofetil
Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
Also known as: MMF
Procedureumbilical cord blood transplantation
One or 2 UCB units may be infused to achieve the required cell dose.
Also known as: UCBT
Radiationtotal body irradiation
Administered Day -1, 200 cGy
Also known as: TBI
DrugSirolimus
Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
Also known as: rapamycin

What researchers measure

Primary outcomes

Number of Participants Who Were Alive at 1 Year Post Transplant
Overall Survival - Number of patients alive at 1 year post transplant
Time frame: 1 Year
Number of Participants Who Were Alive at 2 Years Post Transplant
Overall Survival - Number of patients alive at 2 years post transplant
Time frame: 2 Years

Secondary outcomes

Number of Participants Who Were Dead at 6 Months After Study Completion
Incidence of Non-relapse mortality - Number of Patients Dead at 6 Months after study completion
Time frame: Month 6
Percentage of Donor Chimerism at 21 Days
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Time frame: 21 days
Percentage of Donor Chimerism at 100 Days
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Time frame: 100 days
Percentage of Donor Chimerism at 180 Days
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Time frame: 180 Days
Percentage of Donor Chimerism at 365 Days
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Time frame: 365 days
Number of Participants With Neutrophil Engraftment
Time to 1st 3 consecutive days with absolute neutrophil count (ANC) \> 5 x 10\^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).
Time frame: Day 42
Number of Participants With Platelet Engraftment
Time to platelets \> 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment \>50,000 by day 100.
Time frame: Day 180
Number of Participants With Acute Graft-versus-host Disease (GVHD)
Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
Time frame: Day 100
Number of Participants With Chronic Graft-Versus-Host Disease
Determine the incidence of chronic GVHD at 1 year after transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
Time frame: 1 Year
Number of Participants Experiencing Progression-free Survival
Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression. Patients with leukemia and lymphoma involving the bone marrow (BM) and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
Time frame: 1 Year
Number of Participants Experiencing Progression-free Survival at 2 Years
Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression
Time frame: 2 Years
Number of Participants Experiencing Relapse (Incidence of Relapse)
Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
Time frame: Year 1
Number of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years
Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
Time frame: 2 years

Results

Posted Nov 2, 2020

Participant flow

7 patients were excluded from receiving the treatment as they were not eligible. 4 patients were removed from the study because the participating site withdrew the participation from the study

Participant flow — Overall Study
Milestone	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Started	98	71	7	34	39	35
Completed	98	71	7	34	39	35
Not completed	0	0	0	0	0	0

Outcome measures

PrimaryNumber of Participants Who Were Alive at 1 Year Post Transplant

Overall Survival - Number of patients alive at 1 year post transplant

Time frame:: 1 Year
Reported as:: Count of participants · Participants

Number of Participants Who Were Alive at 1 Year Post Transplant
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants Who Were Alive at 1 Year Post Transplant	59	40	1	26	26	25

PrimaryNumber of Participants Who Were Alive at 2 Years Post Transplant

Overall Survival - Number of patients alive at 2 years post transplant

Time frame:: 2 Years
Reported as:: Count of participants · Participants

Number of Participants Who Were Alive at 2 Years Post Transplant
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants Who Were Alive at 2 Years Post Transplant	50	31	1	20	21	23

SecondaryNumber of Participants Who Were Dead at 6 Months After Study Completion

Incidence of Non-relapse mortality - Number of Patients Dead at 6 Months after study completion

Time frame:: Month 6
Reported as:: Count of participants · Participants

Number of Participants Who Were Dead at 6 Months After Study Completion
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants Who Were Dead at 6 Months After Study Completion	10	20	2	5	3	6

SecondaryPercentage of Donor Chimerism at 21 Days

Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.

Time frame:: 21 days
Reported as:: Mean · percentage of donor cells

Percentage of Donor Chimerism at 21 Days
percentage of donor cells	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Percentage of Donor Chimerism at 21 Days	77 ± 25	73 ± 32	57 ± 29	77 ± 21	69 ± 32	68 ± 33

SecondaryPercentage of Donor Chimerism at 100 Days

Time frame:: 100 days
Reported as:: Mean · percentage of donor cells

Percentage of Donor Chimerism at 100 Days
percentage of donor cells	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Percentage of Donor Chimerism at 100 Days	94 ± 18	94 ± 21	100 ± 0	93 ± 23	85 ± 31	86 ± 32

SecondaryPercentage of Donor Chimerism at 180 Days

Time frame:: 180 Days
Reported as:: Mean · percentage of donor cells

Percentage of Donor Chimerism at 180 Days
percentage of donor cells	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Percentage of Donor Chimerism at 180 Days	96 ± 18	98 ± 6	88 ± 17	94 ± 16	91 ± 26	98 ± 10

SecondaryPercentage of Donor Chimerism at 365 Days

Time frame:: 365 days
Reported as:: Mean · percentage of donor cells

Percentage of Donor Chimerism at 365 Days
percentage of donor cells	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Percentage of Donor Chimerism at 365 Days	99 ± 2	98 ± 12	—	99 ± 6	87 ± 34	100 ± 0

SecondaryNumber of Participants With Neutrophil Engraftment

Time to 1st 3 consecutive days with absolute neutrophil count (ANC) \> 5 x 10\^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).

Time frame:: Day 42
Reported as:: Count of participants · Participants

Number of Participants With Neutrophil Engraftment
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants With Neutrophil Engraftment	93	65	6	32	32	29

SecondaryNumber of Participants With Platelet Engraftment

Time to platelets \> 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment \>50,000 by day 100.

Time frame:: Day 180
Reported as:: Count of participants · Participants

Number of Participants With Platelet Engraftment
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants With Platelet Engraftment	75	47	3	28	34	25

SecondaryNumber of Participants With Acute Graft-versus-host Disease (GVHD)

Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Time frame:: Day 100
Reported as:: Count of participants · Participants

Number of Participants With Acute Graft-versus-host Disease (GVHD)
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants With Acute Graft-versus-host Disease (GVHD)	45	24	1	12	13	13

SecondaryNumber of Participants With Chronic Graft-Versus-Host Disease

Determine the incidence of chronic GVHD at 1 year after transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Time frame:: 1 Year
Reported as:: Count of participants · Participants

Number of Participants With Chronic Graft-Versus-Host Disease
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants With Chronic Graft-Versus-Host Disease	18	20	0	3	3	3

SecondaryNumber of Participants Experiencing Progression-free Survival

Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression. Patients with leukemia and lymphoma involving the bone marrow (BM) and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

Time frame:: 1 Year
Reported as:: Count of participants · Participants

Number of Participants Experiencing Progression-free Survival
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants Experiencing Progression-free Survival	43	32	1	21	16	24

SecondaryNumber of Participants Experiencing Progression-free Survival at 2 Years

Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression

Time frame:: 2 Years
Reported as:: Count of participants · Participants

Number of Participants Experiencing Progression-free Survival at 2 Years
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants Experiencing Progression-free Survival at 2 Years	36	25	1	17	16	20

SecondaryNumber of Participants Experiencing Relapse (Incidence of Relapse)

Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

Time frame:: Year 1
Reported as:: Count of participants · Participants

Number of Participants Experiencing Relapse (Incidence of Relapse)
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants Experiencing Relapse (Incidence of Relapse)	43	14	4	7	20	2

SecondaryNumber of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years

Time frame:: 2 years
Reported as:: Count of participants · Participants

Number of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years
Participants	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
Number of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years	49	19	4	11	20	4

Adverse events

Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm 1-Previous Autologous Transplant	48/98 (49%)	53/98 (54.1%)	76/98 (77.6%)
Arm 2 - No Prior Autologous Transplant	40/71 (56.3%)	48/71 (67.6%)	54/71 (76.1%)
Arm 3 - Refractory Leukemia/Lymphoma	6/7 (85.7%)	3/7 (42.9%)	5/7 (71.4%)
Arm 4: MT2006-01 Coenrolling Patients	14/34 (41.2%)	11/34 (32.4%)	20/34 (58.8%)
Arm 5 - Previous Autologous Transplant	18/39 (46.2%)	2/39 (5.1%)	33/39 (84.6%)
Arm 6 - No Prior Autologous Transplant	12/35 (34.3%)	4/35 (11.4%)	35/35 (100%)

Most frequent serious events

Showing 10 of 16

Most frequent serious events
Event	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps)	19/98	24/71	2/7	1/34	0/39	0/35
RelapseNeoplasms benign, malignant and unspecified (incl cysts and polyps)	19/98	11/71	1/7	3/34	0/39	0/35
Progressive DiseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps)	8/98	2/71	0/7	0/34	0/39	0/35
Graft versus host diseaseImmune system disorders	4/98	5/71	0/7	1/34	0/39	0/35
Blood/Bone Marrow,other - relapse diseaseBlood and lymphatic system disorders	0/98	0/71	0/7	2/34	1/39	2/35
Bone marrow cellularity - aplasiaBlood and lymphatic system disorders	0/98	0/71	0/7	1/34	0/39	0/35
Cardiovascular, other disorder - substernal chest discomfortCardiac disorders	1/98	0/71	0/7	1/34	0/39	0/35
Dermatology/Skin disorderSkin and subcutaneous tissue disorders	0/98	0/71	0/7	1/34	0/39	0/35
Guillamme Barre syndromeNervous system disorders	0/98	0/71	0/7	1/34	0/39	0/35
Primary Graft FailureNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/98	1/71	0/7	0/34	0/39	1/35

Most frequent other events

Showing 10 of 29

Most frequent other events
Event	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant
InfectionInfections and infestations	32/98	18/71	4/7	11/34	33/39	33/35
PneumoniaRespiratory, thoracic and mediastinal disorders	39/98	37/71	4/7	13/34	18/39	20/35
pulmonary hemorrhageRespiratory, thoracic and mediastinal disorders	3/98	10/71	3/7	1/34	1/39	4/35
hyperglycemiaMetabolism and nutrition disorders	4/98	3/71	1/7	3/34	9/39	10/35
IntubationRespiratory, thoracic and mediastinal disorders	12/98	15/71	2/7	5/34	2/39	6/35
neurotoxicityNervous system disorders	2/98	11/71	2/7	1/34	2/39	3/35
Heart disorderCardiac disorders	4/98	6/71	1/7	3/34	6/39	7/35
pericardial effusionCardiac disorders	10/98	14/71	1/7	4/34	5/39	2/35
Engraftment syndromeGeneral disorders	1/98	2/71	0/7	2/34	7/39	3/35
Cytomegaloviral infectionInfections and infestations	13/98	5/71	1/7	2/34	1/39	6/35

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant	Total
<=18 years	7	3	0	0	0	1	11
Between 18 and 65 years	79	55	6	30	29	19	218
>=65 years	12	13	1	4	10	15	55

Sex: Female, Male
Sex: Female, Male(Participants)	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant	Total
Female	37	29	5	16	14	15	116
Male	61	42	2	18	25	20	168

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant	Total
American Indian or Alaska Native	0	1	0	0	0	0	1
Asian	0	2	1	1	0	2	6
Native Hawaiian or Other Pacific Islander	0	1	0	0	0	1	2
Black or African American	6	1	0	2	0	1	10
White	82	61	5	31	39	30	248
More than one race	1	1	0	0	0	0	2
Unknown or Not Reported	9	4	1	0	0	1	15

Region of Enrollment
Region of Enrollment(participants)	Arm 1-Previous Autologous Transplant	Arm 2 - No Prior Autologous Transplant	Arm 3 - Refractory Leukemia/Lymphoma	Arm 4: MT2006-01 Coenrolling Patients	Arm 5 - Previous Autologous Transplant	Arm 6 - No Prior Autologous Transplant	Total
United States	98	71	7	34	39	35	284

Study locations

1 site

Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota 55455, United States

References and documents

Publications

Bachanova V, Verneris MR, DeFor T, Brunstein CG, Weisdorf DJ. Prolonged survival in adults with acute lymphoblastic leukemia after reduced-intensity conditioning with cord blood or sibling donor transplantation. Blood. 2009 Mar 26;113(13):2902-5. doi: 10.1182/blood-2008-10-184093. Epub 2009 Jan 28. PubMed 19179301 ↗
Brunstein CG, Cantero S, Cao Q, Majhail N, McClune B, Burns LJ, Tomblyn M, Miller JS, Blazar BR, McGlave PB, Weisdorf DJ, Wagner JE. Promising progression-free survival for patients low and intermediate grade lymphoid malignancies after nonmyeloablative umbilical cord blood transplantation. Biol Blood Marrow Transplant. 2009 Feb;15(2):214-22. doi: 10.1016/j.bbmt.2008.11.013. PubMed 19167681 ↗
Bachanova V, Burke MJ, Yohe S, Cao Q, Sandhu K, Singleton TP, Brunstein CG, Wagner JE, Verneris MR, Weisdorf DJ. Unrelated cord blood transplantation in adult and pediatric acute lymphoblastic leukemia: effect of minimal residual disease on relapse and survival. Biol Blood Marrow Transplant. 2012 Jun;18(6):963-8. doi: 10.1016/j.bbmt.2012.02.012. Epub 2012 Mar 16. PubMed 22430088 ↗
Bachanova V, Sandhu K, Yohe S, Cao Q, Burke MJ, Verneris MR, Weisdorf D. Allogeneic hematopoietic stem cell transplantation overcomes the adverse prognostic impact of CD20 expression in acute lymphoblastic leukemia. Blood. 2011 May 12;117(19):5261-3. doi: 10.1182/blood-2011-01-329573. Epub 2011 Mar 14. PubMed 21403127 ↗
MacMillan ML, Weisdorf DJ, Brunstein CG, Cao Q, DeFor TE, Verneris MR, Blazar BR, Wagner JE. Acute graft-versus-host disease after unrelated donor umbilical cord blood transplantation: analysis of risk factors. Blood. 2009 Mar 12;113(11):2410-5. doi: 10.1182/blood-2008-07-163238. Epub 2008 Nov 7. PubMed 18997171 ↗

Study documents

Protocol and statistical analysis plan · Nov 8, 2013

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00305682
Lead sponsor: Masonic Cancer Center, University of Minnesota
Responsible party: Sponsor
First posted: Mar 22, 2006
Start date: Jun 2005
Primary completion: Dec 12, 2019
Completion: Dec 12, 2019
Results posted: Nov 2, 2020
Last update: Nov 19, 2020

Study contacts

Claudio G. Brunstein, MD, PhD

principal investigator · Masonic Cancer Center, University of Minnesota

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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