Clinical trial · Interventional

AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders

Allogeneic Stem Cell Transplantation for Patients With Hematological Malignancies Using Multiple Unrelated Cord Blood Units

NCT00547196CI-TRIAL-00077952completedN/AResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the 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 make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well four different chemotherapy regimens given with or without total-body irradiation before umbilical cord blood transplant work in treating patients with relapsed or refractory hematologic cancer.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (11)

Intervention	Type	Mapped drug	Match
allogeneic hematopoietic stem cell transplantation	Procedure	—	UNRESOLVED
Busulfan	Drug	Busulfan	ALIAS
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Cyclosporine	Drug	—	UNRESOLVED
filgrastim	Biological	Filgrastim	ALIAS
Fludarabine phosphate	Drug	Fludarabine	ALIAS
Fractionated total body irradiation	Radiation	—	UNRESOLVED
Melphalan	Drug	Melphalan	ALIAS

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
Regimen I (FTBI, Cyclophosphamide, Fludarabine)
description
Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
interventionNames
1. Biological: filgrastim
2. Drug: Cyclophosphamide
3. Drug: Cyclosporine
4. Drug: Fludarabine phosphate
5. Drug: Mycophenolate Mofetil
6. Procedure: allogeneic hematopoietic stem cell transplantation
7. Procedure: umbilical cord blood transplantation
8. Radiation: Fractionated total body irradiation
type
EXPERIMENTAL
label
Regimen II (Busulfan, Fludarabine, Melphalan)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 0 Years
Maximum age: 120 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed hematological or lymphatic malignancy, including any of the following:

  * Acute myeloid leukemia

    * Relapsed or primary refractory disease with \< 10% blasts on peripheral blood smear
    * In first remission with poor risk factors and molecular prognosis \[i.e., AML with -5, -7, t(6;9), tri8, -11\] (preparative regimen 3 or 4)
  * Acute lymphocytic leukemia

    * In second complete remission or higher OR in first remission with poor risk factors, including any of the following (preparative regimen 1 or 2):

      * BCR/ABL by fluorescence in situ hybridization (FISH) or reverse transcriptase-polymerase chain reaction
      * t(9;22)(q34;q11) detected by cytogenetics
      * Chromosomes \< 44 by cytogenetics
      * DNA index \< 0.81 by flow cytometry
      * Any rearrangement of chromosome 11 that results in disruption of MLL gene (11q23) by cytogenetics and SER
    * In first remission with poor risk factors and molecular prognosis \[ALL with Philadelphia chromosome-positive t(9;22), t(4;22), (q34;q11)\] (preparative regimen 3 or 4)
  * Chronic myelogenous leukemia

    * In accelerated phase or greater (preparative regimen 1 or 2)
    * In accelerated or second chronic phase (preparative regimen 3 or 4)
  * Myelodysplastic syndromes

    * With deletion of chromosome 7 or short arm of chromosome 5 (preparative regimen 1 or 2)
    * In high and high-intermediate risk categories (preparative regimen 3 or 4)
  * Non-Hodgkin lymphoma in relapse with marrow involvement
  * Refractory chronic lymphocytic leukemia
* Patients deemed ineligible for conventional high-dose chemotherapy programs (i.e., regimens 1 or 2) due to any of the following concurrent medical conditions may be eligible for regimens 3 or 4 at the discretion of the treating physician and principal investigator (preparative regimen 3 or 4):

  * LVEF \< 50% and \> 40%
  * FEV1, FVC, or DLCO \< 50%
  * Bilirubin \> 3 mg/dL
  * Creatinine \> 2 mg/dL
* Two partially HLA-matched umbilical cord blood (UCB) units available

  * HLA-matched minimally at 4 of 6 HLA-A, HLA-B, and -DRB1 loci with the patient

    * DRB1 matched by high resolution DNA typing
    * HLA-A and HLA-B matched by low resolution at the "serological match" level
  * Two pooled units with a nucleated cell number \> 2.5 x 10\^7/kg
* No available HLA-identical sibling or 1 antigen-mismatched related donor
* No available HLA-matched unrelated bone marrow donor

PATIENT CHARACTERISTICS:

* See Disease Characteristics
* Karnofsky performance status (PS) 60-100% OR Lansky PS 60-100% OR Zubrod PS 0-1
* Physiological age 60 or less (at any chronological age)
* Weight \> 50 kg
* Creatinine normal for age OR creatinine clearance by 24-hour urine collection or glomerular filtration rate \> 60 mL/min
* Bilirubin ≤ 1.5 mg/dL
* LVEF ≥ 50%
* DLCO ≥ 60% of predicted
* No HIV-1 infection
* No active uncontrolled infection
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* Recovered from prior intensive chemotherapy

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment