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CompletedNCT00056966Updated Jun 29, 2012

Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation of Patients With Hematological Diseases

A Phase 1/2 interventional study of ANTI-CD45 and CAMPATH-1H in Hematologic Malignancy, sponsored by Baylor College of Medicine. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2012-06-29.

Sponsored by Baylor College of Medicine · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Sex
All
01

Study summary

Participants in this study have a hematologic malignancy (a disorder in the bone marrow that affects the body's ability to create blood) that might benefit from receiving an allogeneic stem cell transplant (meaning the cells come from a donor) from a family member or nearly identical matched donor. The donor may either be a matched sibling, a mismatched family member, or an unrelated person.

Usually these patients are given high doses of chemotherapy before receiving a stem cell transplant to keep their immune system from rejecting the donor stem cells and to kill any diseased cells that remain in the body. However, this group of patients have a high risk of developing possibly life-threatening treatment-related side effects such as infections, damage to vital organs such as lungs, liver, kidney and heart, as well as graft versus host disease (GVHD).

Instead of the high dose chemotherapy and radiotherapy usually given before a transplant, this research study uses a new pre-transplant combination of three drugs, Fludarabine, Anti-CD45 and CAMPATH-1H with low dose radiotherapy. Fludarabine is a chemotherapy drug while Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells, including those which are causing this disease. CAMPATH-1H is particularly important because it stays active in the body for a long time after it is given, which means it may work longer to prevent GVHD symptoms. Anti-CD45 may help in eradicating residual malignant cells. All these agents also help in preventing rejection of donor stem cells. This study is designed to give a less intense chemotherapy and radiotherapy, so that the life-threatening toxicities of conventional high dose chemotherapy and radiotherapy regimen can be reduced, while maintaining the ability to cure cancer.

Read the detailed description

CAMPATH-1H will be given as a daily IV infusion for three days. Fludarabine will be given as a daily IV infusion for four days. Anti-CD45 will be given as a daily IV infusion for 4 days. Patients will then receive radiotherapy (also known as Total Body Irradiation or TBI) for one day. A summary of the treatment follows:

  • Day - 8: CAMPATH-1H and Fludarabine
  • Day - 7: CAMPATH-1H and Fludarabine
  • Day - 6: CAMPATH-1H and Fludarabine
  • Day - 5: Anti-CD45 and Fludarabine
  • Day - 4: Anti-CD45
  • Day - 3: Anti-CD45
  • Day - 2: Anti-CD45
  • Day - 1: TBI
  • Day 0: Stem Cell Infusion (transplant)

To help prevent the body from developing GVHD, patients will also receive the drug FK506, starting two days before the transplant and continuing for at least one month.

Both the CAMPATH-1H and the Anti-CD45 can cause allergic reactions so patients will be given drugs to help prevent those reactions before receiving daily doses.

To see how CAMPATH-1H works in patients with hematologic malignancies, some patients will be asked to participate in pharmacokinetic studies. For this, approximately 13 blood samples will be taken from the central line scheduled before each infusion on Day -8 to Day -6, daily thereafter until Day 0, and then approximately once per week on days 7, 14, 21 and 28 post transplant. No more than 5 teaspoonfuls total will be drawn.

To see how Anti-CD45 works in patients with hematologic malignancies some patients will be asked to participate in pharmacokinetic studies. Approximately 22 blood samples will be taken from the central line scheduled before, during and after each infusion and after the end of the last infusion of Anti-CD45. No more than 10 teaspoonfuls total will be drawn over the course of the four anti-CD45 infusions.

02

Conditions studied

  • Hematologic Malignancy

Keywords

  • Acute myeloid leukemia
  • Acute lymphoblastic leukemia
  • Chronic myeloid leukemia
  • Non-Hodgkin's lymphoma
  • Hodgkin's disease
  • Myelodysplastic syndrome
  • Myeloproliferative disorders
  • Multiple myeloma
  • Severe aplastic anemia
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's enrollment of 24 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with one of the following high risk diseases needing allogeneic hemopoietic stem cell transplantation:

    Acute myeloid leukemia either a) Primary refractory, or b) Beyond first complete remission(CR1), or c) In CR1 with high risk of relapse

    Acute lymphoblastic leukemia either a) Primary refractory, or b) Beyond first complete remission(CR1), or c) In CR1 with high risk of relapse

    Chronic myeloid leukemia, either a) Accelerated phase, or b) Blast crisis, or c) Chronic phase and not achieving major cytogenetic response despite standard therapy

    Chronic lymphocytic leukemia, either a) Primary refractory, or b) Beyond first complete remission(CR1),

    Non Hodgkin's lymphoma, either a) Primary refractory, or b) Beyond first complete remission(CR1)

    Hodgkin's disease, either a) Primary refractory, or b) Beyond first complete remission(CR1),

    Myelodysplastic syndrome with IPSS score > 0. (Appendix A)

    Myeloproliferative disorders (with the exclusion of chronic myeloid leukemia) a) Primary Myelofibrosis with Lile score of 1 or 2 (Appendix B) b) Polycythemia Vera or Essential Thrombocythemia transformed to AML or Myelofibrosis and PV "spent phase"

    Multiple Myeloma with stage II or III disease

    Severe aplastic anemia

  2. Conditions that increase Treatment Related Mortality (need one or more to be eligible):

    Greater or equal to 35 years of age;

    Ejection Fraction of less than 50%;

    DLCO less than 50% or FEV1/FVC \< 80% of predicted value;

    Diabetes Mellitus;

    Renal insufficiency (serum creatinine abnormal);

    Hepatic dysfunction-transaminases, or alkaline phosphatase, or bilirubin twice the upper limit of normal;

    Prior recent history of systemic fungal infection;

    Multiple prior treatment regimens (equal to or more than 3);

    Significant Grade III or IV neurologic, cardiac, pulmonary, renal or hepatic toxicity from previous treatment;

    Prior Autologous or Allogeneic Stem Cell transplantation;

  3. Available Healthy Donor without any contraindications for donation. 5/6 or 6/6 related or unrelated donor (molecular typing for DRB1);
  4. Patient and/or responsible person able to understand and sign consent

Exclusion criteria

Exclusion Criteria:

Pregnant and lactating women, or women unwilling to use contraception.

HIV positive patient

Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)

Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)

Child's class C cirrhosis

Unstable cerebral vascular disease or recent hemorrhagic stroke (less than 6 months)

Patients with known allergy to rat serum products

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    1

    recipients of HLA matched sibling transplants

    Drug: ANTI-CD45 · Drug: CAMPATH-1H · Drug: FK506 · Drug: Fludarabine · Radiation: Total Body Irradiation · Procedure: Stem cell infusion

  • Experimental
    2

    recipients of unrelated or mismatched family donor transplants

    Drug: ANTI-CD45 · Drug: CAMPATH-1H · Drug: FK506 · Drug: Fludarabine · Radiation: Total Body Irradiation · Procedure: Stem cell infusion

Interventions

  • DrugANTI-CD45

    400ug/kg Day-5 through Day-2

  • DrugCAMPATH-1H

    Day -8 through Day -6 Dosed per Institutional SOP

    Also known as: anti-CD52, alemtuzumab

  • DrugFK506

    Day -2 through Day 30 dose adjusted to maintain level between 5-15 ng/ml.

    Also known as: tacrolimus

  • DrugFludarabine

    Day-8 through Day-5 30 mg/m2

  • RadiationTotal Body Irradiation

    Day-1 single dose 450 cGy

  • ProcedureStem cell infusion

    Patients will receive peripheral blood stem cells from a HLA matched or one antigen mismatched related or unrelated donor (target CD34+ cell count \>2 x 106/kg). When peripheral stem cells are unavailable or insufficient, bone marrow (target mononuclear cell count \>2 x 108/kg) will be substituted.

06

What researchers measure

Primary outcomes

  1. Assess safety and feasibility of monoclonal abs directed to CD45 and CD52 antigens, Fludarabine and low dose TBI, as a non-myeloablative preparatory regimen for allo HSCT. This will be determined by 100d Non-relapse mortality and 100d Graft rejection

    Time frame: 100 days post transplant

Secondary outcomes

  1. To obtain a preliminary estimate of the efficacy of this therapy as defined by: Complete remission at day 100 and One-year disease free survival.

    Time frame: 100 days and 1 year post transplant

07

Study locations

2 sites
  • Texas Children's Hospital
    Houston, Texas 77030, United States
  • The Methodist Hospital
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00056966
Lead sponsor
Baylor College of Medicine
Collaborators
The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
Responsible party
George Carrum (Associate Professor, Baylor College of Medicine) — Principal investigator
First posted
Mar 27, 2003
Start date
Nov 2002
Primary completion
May 2005
Completion
Dec 2006
Last update
Jun 29, 2012

Study contacts

Malcolm K Brenner, MD
study chair · Baylor College of Medicine

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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