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CompletedNCT00040846Updated Jan 29, 2020Results posted

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

A Phase 2 interventional study of alemtuzumab and fludarabine phosphate in Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q) and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Fred Hutchinson Cancer Center. Completed at 7 sites in 2 countries. Open to participants aged Up to 74 Years. Per ClinicalTrials.gov, last updated 2020-01-29.

Primary conditionLymphoma, Extranodal NK-T-CellRegistry: Congenital AbnormalitiesReclassifiedWhy we changed it
Registry
Congenital Abnormalities — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lymphoma, Extranodal NK-T-Cell
Why
  1. Congenital Abnormalities is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Lymphoma, Extranodal NK-T-Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2001, registered Jul 2002).
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
Up to 74 Years
Sex
All
01

Study summary

This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine whether stable allogeneic engraftment from related and unrelated human leukocyte antigen (HLA)-mismatched stem cell donors can be safely established using a non-myeloablative conditioning regimen plus escalating doses of the anti-CD52 monoclonal antibody (mAb) Campath (alemtuzumab) in patients with hematologic malignancies.

SECONDARY OBJECTIVES:

I. Evaluate the risk of occurrence of acute and chronic graft-vs-host disease (GVHD).

II. Evaluate the risk/incidence of infections.

III. Determine whether engraftment can be maintained with a single dose fludarabine, donor lymphocyte infusion (DLI) and continued MMF/CSP.

IV. Evaluate the risk for disease progression and relapse.

OUTLINE: This is a dose-escalation study of alemtuzumab.

CONDITIONING REGIMEN: Patients receive alemtuzumab intravenously (IV) over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT): Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or orally (PO) twice daily (BID) on days -3 to 180 with taper to day 365 and MMF PO thrice daily (TID) on days 0-100 with taper to day 156.

After completion of study treatment, patients are followed up periodically.

02

Conditions studied

  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Childhood Burkitt Lymphoma
  • Childhood Chronic Myelogenous Leukemia
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • Childhood Nasal Type Extranodal NK/T-cell Lymphoma
  • Chronic Phase Chronic Myelogenous Leukemia
  • Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
  • Contiguous Stage II Grade 1 Follicular Lymphoma
  • Contiguous Stage II Grade 2 Follicular Lymphoma
  • Contiguous Stage II Marginal Zone Lymphoma
  • Contiguous Stage II Small Lymphocytic Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Nodal Marginal Zone B-cell Lymphoma
  • Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
  • Noncontiguous Stage II Grade 1 Follicular Lymphoma
  • Noncontiguous Stage II Grade 2 Follicular Lymphoma
  • Noncontiguous Stage II Marginal Zone Lymphoma
  • Noncontiguous Stage II Small Lymphocytic Lymphoma
  • Peripheral T-cell Lymphoma
  • Previously Treated Myelodysplastic Syndromes
  • Progressive Hairy Cell Leukemia, Initial Treatment
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Anaplastic Large Cell Lymphoma
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Hairy Cell Leukemia
  • Refractory Multiple Myeloma
  • Relapsing Chronic Myelogenous Leukemia
  • Splenic Marginal Zone Lymphoma
  • Stage I Adult Diffuse Small Cleaved Cell Lymphoma
  • Stage I Childhood Anaplastic Large Cell Lymphoma
  • Stage I Childhood Large Cell Lymphoma
  • Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage I Grade 1 Follicular Lymphoma
  • Stage I Grade 2 Follicular Lymphoma
  • Stage I Mantle Cell Lymphoma
  • Stage I Marginal Zone Lymphoma
  • Stage I Mycosis Fungoides/Sezary Syndrome
  • Stage I Small Lymphocytic Lymphoma
  • Stage II Childhood Anaplastic Large Cell Lymphoma
  • Stage II Childhood Large Cell Lymphoma
  • Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage II Mycosis Fungoides/Sezary Syndrome
  • Stage III Adult Diffuse Large Cell Lymphoma
  • Stage III Adult Diffuse Small Cleaved Cell Lymphoma
  • Stage III Childhood Anaplastic Large Cell Lymphoma
  • Stage III Childhood Large Cell Lymphoma
  • Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage III Grade 1 Follicular Lymphoma
  • Stage III Grade 2 Follicular Lymphoma
  • Stage III Mantle Cell Lymphoma
  • Stage III Marginal Zone Lymphoma
  • Stage III Mycosis Fungoides/Sezary Syndrome
  • Stage III Small Lymphocytic Lymphoma
  • Stage IV Adult Diffuse Large Cell Lymphoma
  • Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
  • Stage IV Childhood Anaplastic Large Cell Lymphoma
  • Stage IV Childhood Large Cell Lymphoma
  • Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IV Grade 1 Follicular Lymphoma
  • Stage IV Grade 2 Follicular Lymphoma
  • Stage IV Mantle Cell Lymphoma
  • Stage IV Marginal Zone Lymphoma
  • Stage IV Mycosis Fungoides/Sezary Syndrome
  • Stage IV Small Lymphocytic Lymphoma
  • T-cell Large Granular Lymphocyte Leukemia
  • Waldenström Macroglobulinemia
03

In context

Lymphoma, Extranodal NK-T-Cell Reclassified

270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.

This study's enrollment of 60 is above the median of 33 across 225 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.

Browse Lymphoma, Extranodal NK-T-Cell studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 547 studies on the registry; 80 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.

Browse Fred Hutchinson Cancer Center studies →

Compared within Lymphoma, Extranodal NK-T-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Congenital Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Up to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must be not eligible for conventional transplants and must have disease expected to be stable for at least 100 days without chemotherapy; patients with hematologic treatable with hematopoietic stem cell transplant () or with a B cell malignancy except those treatable with autologous transplant will be included

  • Aggressive non-Hodgkin lymphomas (NHLs) and Other Histologies Such as Diffuse large B cell NHL

    • Patients with primary or relapsed disease not eligible for an autologous transplant
    • Patients are eligible following an autologous transplant in remission or in relapse
    • Planned tandem transplant is allowed for patients at high risk of relapse
  • Low grade NHL with \< 6 months duration of complete remission (CR) between courses of conventional therapy
  • Mantle Cell NHL may be treated in first CR
  • Chronic lymphocytic leukemia (CLL) - Must have failed 2 lines of conventional therapy and be refractory to fludarabine
  • Hodgkin disease (HD) - Must have received and failed frontline therapy; patients must have had a prior autologous transplant or were not eligible for autologous transplant; planned tandem transplants are allowed for patients at high risk of relapse
  • Multiple myeloma (MM) - Must have received prior chemotherapy and a prior autologous transplant, unless autologous transplant was not possible; planned tandem transplants are allowed for patients at high risk of relapse
  • Acute myeloid leukemia (AML) - Must have \< 5% marrow blasts at the time of transplant
  • Acute lymphocytic leukemia (ALL) - Must have \< 5% blasts at the time of transplant
  • Chronic myeloid leukemia (CML) - Patients will be accepted beyond chronic phase 1 (CP1) if they have received previous myelosuppressive chemotherapy or HSCT, and have \< 5% marrow blasts at time of transplant
  • Myelodysplastic (MDS)/Myeloproliferative disorders - Must have failed previous myelosuppressive chemotherapy or HSCT, and have \< 5% marrow blasts at time of transplant
  • Waldenstrom's Macroglobulinemia - Must have failed 2 courses of therapy
  • Patients \< 12 years old must be approved by the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator (PI)
  • Patients who refuse to be treated on a conventional transplant protocol; for this inclusion, criteria transplants must be approved by both the participating institution´s patient review committee such as the Patient Care Conference (PCC) at the FHCRC and the FHCRC principal investigator

  • Patients with related or unrelated donors for whom

    • The best available match is a HLA class II DRB1 and DQB1 matched donor incompatible for any single serologically detectable class I HLA-A, -B, -C mismatch; one additional allele level class I mismatch is allowed OR any combination of 2 allele level mismatches (if typed at the molecular level)
    • There is a likelihood of rapid disease progression while HLA typing and results of a preliminary search and the donor pool suggests that a 10/10 HLA-A, B, C, DRB1 and DQB1 matched unrelated donor will not be found
    • There is no HLA-A, -B or -C one locus allelic mismatched related donor available
    • There is no indication for an autologous transplantation as a treatment option

  • DONOR: Related or unrelated donors who are matched for HLA-DRB1 and DQB1 alleles (must be defined by high resolution typing), and who are mismatched for:

    • Any single serologically detectable HLA-A or B or C antigen +/- 1 allele or
    • Any combination of two HLA-A, -B, or -C alleles (if prospectively typed at molecular level)

Exclusion criteria

Exclusion Criteria:

  • Patients who are homozygous at the mismatched major histocompatibility complex (MHC) class I locus
  • A positive cross-match exists between the donor and recipient
  • Patients with rapidly progressive intermediate or high grade NHL
  • Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology for patients with AML, ALL or CML
  • severely limited by diseases other than
  • Central nervous system (CNS) involvement with disease to intrathecal chemotherapy
  • Fertile men or women unwilling to use during and for up to 12 months post treatment
  • Female patients who are pregnant or breast-feeding
  • (HIV) positive patients
  • Patients with active non-hematologic malignancies (except non-melanoma skin cancers)
  • Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence
  • Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
  • Patients with active bacterial or fungal infections unresponsive to medical therapy

  • Patients with the following organ dysfunction symptomatic coronary artery disease or \< 35% or other cardiac failure requiring therapy; ejection fraction is required if the patient is > 50 years of age, or history of cardiac disease or anthracycline exposure

    • Diffusion capacity of carbon monoxide (DLCO) \< 35%; total lung capacity (TLC) \< 35%; or (FEV1) \< 35% and/or receiving supplementary continuous oxygen
    • Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, bridging fibrosis, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure; cirrhosis of the liver with evidence of portal hypertension; alcoholic hepatitis; esophageal varices; a history of bleeding esophageal varices; hepatic encephalopathy; uncorrectable hepatic synthetic dysfunction evinced by prolongation of the ; ascites related to portal hypertension; bacterial or fungal liver abscess; biliary obstruction; chronic viral hepatitis with total serum >3 mg/dL; or symptomatic biliary disease
    • Patients with poorly controlled hypertension on multiple antihypertensives
    • score \< 70 for adult patients
    • Lansky-Play Performance Score \< 50 for pediatric patients
  • DONOR: Bone marrow (BM) donors
  • DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for granulocyte colony-stimulating factor (G-CSF) mobilization and harvest of peripheral blood stem cell (PBSC)
  • DONOR: Donors \< 12 years of age
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Treatment (dose-escalation of alemtuzumab, HSCT)

    CONDITIONING REGIMEN: Patients receive alemtuzumab IV over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

    Biological: alemtuzumab · Drug: fludarabine phosphate · Radiation: total-body irradiation · Procedure: allogeneic hematopoietic stem cell transplantation · Procedure: peripheral blood stem cell transplantation · Drug: mycophenolate mofetil · Drug: cyclosporine

Interventions

  • Biologicalalemtuzumab

    Given IV

    Also known as: anti-CD52 monoclonal antibody, Campath-1H, MoAb CD52, Monoclonal Antibody Campath-1H, Monoclonal Antibody CD52

  • Drugfludarabine phosphate

    Given IV

    Also known as: 2-F-ara-AMP, Beneflur, Fludara

  • Radiationtotal-body irradiation

    Undergo TBI

    Also known as: TBI

  • Procedureallogeneic hematopoietic stem cell transplantation

    Undergo allogeneic HSCT

  • Procedureperipheral blood stem cell transplantation

    Undergo allogeneic peripheral blood stem cell transplantation

    Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell

  • Drugmycophenolate mofetil

    Given PO

    Also known as: Cellcept, MMF

  • Drugcyclosporine

    Given IV or PO

    Also known as: ciclosporin, cyclosporin, cyclosporin A, CYSP, Sandimmune

06

What researchers measure

Primary outcomes

  1. Evaluate the Risk of Transplant Related Mortality.

    Percentage patients with Day 100 transplant related mortality.

    Time frame: 100 days after transplant

  2. Evaluate the Risk of Occurrence of Acute and Chronic GVHD

    Percentage patients who developed acute/chronic GVHD. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma with bullous formation and often with desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

    Time frame: 1 year after transplant

  3. Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.

    Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as \> 95% donor CD3+ T cells.

    Time frame: 100 days after transplant

Secondary outcomes

  1. Evaluate the Risk/Incidence of Infections

    Percentage patients who experienced infections within 100 days post-transplant.

    Time frame: 100 days after transplant

  2. Evaluate the Risk for Disease Progression and Relapse

    Percentage patients who relapsed/progressed within 1 year post-transplant.

    Time frame: 1 year after transplant

07

Results

Posted Mar 16, 2017

Participant flow

Participant flow — Overall Study
MilestoneDose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)
Started6000000
Completed6000000
Not completed000000

Outcome measures

PrimaryEvaluate the Risk of Transplant Related Mortality.

Percentage patients with Day 100 transplant related mortality.

Time frame:
100 days after transplant
Reported as:
Number · percentage of participants
Evaluate the Risk of Transplant Related Mortality.
percentage of participantsDose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)
Evaluate the Risk of Transplant Related Mortality.20—————
PrimaryEvaluate the Risk of Occurrence of Acute and Chronic GVHD

Percentage patients who developed acute/chronic GVHD. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma with bullous formation and often with desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Time frame:
1 year after transplant
Reported as:
Number · percentage of participants
Evaluate the Risk of Occurrence of Acute and Chronic GVHD
percentage of participantsDose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)
Grade III-IV aGVHD23.3—————
cGVHD41.7—————
PrimaryDetermine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.

Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as \> 95% donor CD3+ T cells.

Time frame:
100 days after transplant
Reported as:
Number · percentage of participants
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.
percentage of participantsDose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)
CD3 - Graft rejection3.3—————
CD3 - Mixed chimerism18.3—————
CD3 - Full donor chimerism70—————
CD3 - Unknown8.33—————
CD33 - Graft Rejection1.7—————
CD33 - Mixed chimerism3.3—————
CD33 - Full donor chimerism80—————
CD33 - Unknown15—————
SecondaryEvaluate the Risk/Incidence of Infections

Percentage patients who experienced infections within 100 days post-transplant.

Time frame:
100 days after transplant
Reported as:
Number · percentage of participants
Evaluate the Risk/Incidence of Infections
percentage of participantsDose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)
Evaluate the Risk/Incidence of Infections91.7—————
SecondaryEvaluate the Risk for Disease Progression and Relapse

Percentage patients who relapsed/progressed within 1 year post-transplant.

Time frame:
1 year after transplant
Reported as:
Number · percentage of participants
Evaluate the Risk for Disease Progression and Relapse
percentage of participantsDose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)
Evaluate the Risk for Disease Progression and Relapse21.7—————

Adverse events

Collected over AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dose Level 1 (No Campath)—24/60 (40%)33/60 (55%)
Dose Level 2 (0.025 mg/kg/Day Campath)———
Dose Level 3 (0.050 mg/kg/Day Campath)———
Dose Level 4 (0.10 mg/kg/Day Campath)———
Dose Level 5 (0.20 mg/kg/Day Campath)———
Dose Level 6 (0.40 mg/kg/Day Campath)———
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventDose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)
GVHDImmune system disorders8/60—————
SepsisInfections and infestations5/60—————
Multi-organ failureGeneral disorders4/60—————
Respiratory failureRespiratory, thoracic and mediastinal disorders3/60—————
Cardiac troponin I increasedCardiac disorders1/60—————
Heart failureCardiac disorders1/60—————
Gastric perforationGastrointestinal disorders1/60—————
Secondary MalignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/60—————
LeukoencephalopathyNervous system disorders1/60—————
HypoxiaRespiratory, thoracic and mediastinal disorders1/60—————
Most frequent other events
Showing 10 of 41
Most frequent other events
EventDose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)
Blood bilirubin increasedInvestigations13/60—————
HypoxiaRespiratory, thoracic and mediastinal disorders10/60—————
Creatinine increasedInvestigations5/60—————
HypotensionVascular disorders4/60—————
HypertensionVascular disorders3/60—————
Myocardial infactionCardiac disorders3/60—————
Thromboembolic eventVascular disorders3/60—————
Ventricular arrhythmiaCardiac disorders3/60—————
Acute kidney injuryRenal and urinary disorders2/60—————
Atrial fibrillationCardiac disorders2/60—————

Baseline characteristics

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Age, Categorical
Age, Categorical(Participants)Dose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)Total
<=18 years1—————1
Between 18 and 65 years52—————52
>=65 years7—————7
Age, Continuous
Age, Continuous(years)Dose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)Total
Median56.7 (13 to 72)—————56.7 (13 to 72)
Sex: Female, Male
Sex: Female, Male(Participants)Dose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)Total
Female15—————15
Male45—————45
Region of Enrollment
Region of Enrollment(participants)Dose Level 1 (No Campath)Dose Level 2 (0.025 mg/kg/Day Campath)Dose Level 3 (0.050 mg/kg/Day Campath)Dose Level 4 (0.10 mg/kg/Day Campath)Dose Level 5 (0.20 mg/kg/Day Campath)Dose Level 6 (0.40 mg/kg/Day Campath)Total
United States60—————60
08

Study locations

7 sites
  • Presbyterian - Saint Lukes Medical Center - Health One
    Denver, Colorado 80218, United States
  • Huntsman Cancer Institute/University of Utah
    Salt Lake City, Utah 84112, United States
  • LDS Hospital
    Salt Lake City, Utah 84143, United States
  • VA Puget Sound Health Care System
    Seattle, Washington 98101, United States
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
  • Froedtert Memorial Lutheran Hospital, Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • University of Torino
    Torino, 10126, Italy
09

References and documents

Publications

  • Nakamae H, Storer BE, Storb R, Storek J, Chauncey TR, Pulsipher MA, Petersen FB, Wade JC, Maris MB, Bruno B, Panse J, Petersdorf E, Woolfrey A, Maloney DG, Sandmaier BM. Low-dose total body irradiation and fludarabine conditioning for HLA class I-mismatched donor stem cell transplantation and immunologic recovery in patients with hematologic malignancies: a multicenter trial. Biol Blood Marrow Transplant. 2010 Mar;16(3):384-94. doi: 10.1016/j.bbmt.2009.11.004. Epub 2009 Nov 10. PubMed 19900571 ↗
10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2001 to primary completion in Dec 2009, 97 months.

Results were first posted in Mar 2017, 7 years 3 months after primary completion.

Of 39 phase 2 interventional studies under Lymphoma, Extranodal NK-T-Cell, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 99. This study's 97 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2002
First posted
Jan 27, 2003
StartActual
Nov 2001
Primary completionActual
Dec 2009
CompletionActual
Dec 2009
Results first posted
Mar 16, 2017
Last update
Jan 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00040846
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI)
Responsible party
Brenda Sandmaier (Principal Investigator, Fred Hutchinson Cancer Center) — Principal investigator
First posted
Jan 27, 2003
Start date
Nov 2001
Primary completion
Dec 2009
Completion
Dec 2009
Results posted
Mar 16, 2017
Last update
Jan 29, 2020

Study contacts

Brenda Sandmaier
principal investigator · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Alemtuzumab · Fludarabine phosphate

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