Clinical trial · Interventional

Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders

A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders

NCT00544115CI-TRIAL-00113365active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell 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 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 make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating patients with advanced hematologic cancer or other disorders.

Conditions

Conditions (8)

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

Condition (as posted)	Mapped entity	Match	Confidence
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Graft Versus Host Disease	—	UNRESOLVED	—
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Multiple Myeloma and Plasma Cell Neoplasm	—	UNRESOLVED	—
Myelodysplastic/Myeloproliferative Diseases	Myelodysplastic/Myeloproliferative Neoplasm	ALIAS	0.90
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90
Precancerous/Nonmalignant Condition	—

Interventions

Interventions (13)

Intervention	Type	Mapped drug	Match
allogeneic hematopoietic stem cell transplantation	Procedure	—	UNRESOLVED
busulfan	Drug	Busulfan	ALIAS
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
cyclosporine	Drug	—	UNRESOLVED
etoposide	Drug	Etoposide	ALIAS
fludarabine phosphate	Drug	Fludarabine	ALIAS
melphalan	Drug	Melphalan	ALIAS
methotrexate	Drug	Methotrexate	ALIAS

Design

Arms and outcomes

Arms (6)

type
ACTIVE_COMPARATOR
label
Regimen I
description
Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
interventionNames
1. Drug: cyclophosphamide
2. Drug: cyclosporine
3. Drug: methotrexate
4. Drug: mycophenolate mofetil
5. Drug: sirolimus
6. Drug: tacrolimus
7. Procedure: allogeneic hematopoietic stem cell transplantation
8. Procedure: peripheral blood stem cell transplantation
9. Radiation: total-body irradiation
type
ACTIVE_COMPARATOR
label
Regimen II
description
Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
interventionNames

Eligibility

Eligibility (as posted)

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

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of one of the following:

  * Acute lymphocytic leukemia (ALL), meeting one of the following criteria:

    * In first relapse or beyond
    * High-risk ALL, defined by any of the following:

      * Hypoploidy (≤ 44 chromosomes)
      * Pseudodiploidy with translocations or molecular evidence of t(9;22), 11q23, or t(8;14), excluding B-cell ALL
      * Elevated WBC at presentation (WBC \> 20,000/mm³ \[for patients \> 18 years of age\]; WBC \> 200,000/mm³ \[for patients 12-18 years of age\])
  * Acute myeloid leukemia (AML), meeting one of the following criteria:

    * In first complete remission
    * Failed to achieve remission
    * In first relapse or beyond
    * Secondary AML (\> 30% blasts in marrow aspirate)

      * Should receive induction chemotherapy to obtain remission, if possible, before transplant
  * Chronic myelogenous leukemia, meeting one of the following criteria:

    * In first or second chronic phase or accelerated phase
    * In blast crisis, defined as \> 30% promyelocytes plus blasts in the bone marrow
  * Myelodysplastic syndromes, including any of the following:

    * Refractory anemia with excess blasts (RAEB)
    * Chronic myelomonocytic leukemia
    * RAEB in transformation
  * Refractory non-Hodgkin lymphoma, chronic lymphocytic leukemia, Hodgkin lymphoma, or multiple myeloma

    * Received and failed front-line therapy, high-dose therapy and autologous stem cell transplantation, or salvage therapy
  * Myeloproliferative disorders/myelofibrosis may be allowed on a case by case basis
  * Severe aplastic anemia, paroxysmal nocturnal hemoglobinuria, or any other hematologic disorder requiring transplantation
* Patients \> 55 years of age with hematologic diseases treatable by allogeneic stem cell transplantation who are not eligible for IRB 99190 are eligible
* No uncontrolled CNS involvement of disease
* No matched (6/6) related donor available
* HLA-identical unrelated donor available

  * HLA-phenotypically identical for HLA-A and HLA-B alleles and identical for DRB1 alleles by DNA typing for both class I and class II antigens

    * Allele mismatch for HLA class I (i.e., B 2701 vs B 2702) allowed if no alternative donors
    * Allele mismatch for class II (i.e., DRB1 0401 vs 0402) or minor mismatch for class I cross reactive group (CREG) (i.e., A 2 vs A 28) allowed in patients ≤ 35 years of age requiring urgent transplant

PATIENT CHARACTERISTICS:

* Karnofsky performance status 50-100%
* Life expectancy \> 8 weeks
* LVEF ≥ 45% at rest
* AST ≤ 2 times normal (unless liver function abnormality is due to underlying disease)
* Total bilirubin \< 1.5 times normal (unless liver function abnormality is due to underlying disease)
* Creatinine ≤ 1.5 times normal OR creatinine clearance ≥ 60 mL/min
* DLCO ≥ 40% of predicted (corrected for hemoglobin)
* No coexisting medical problem that would significantly increase the risk of the transplant procedure
* HIV negative
* Not pregnant

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment