Clinical trial · Interventional

NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders

Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders

NCT00053989CI-TRIAL-00043302completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.

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
Aplastic Anemia	—	UNRESOLVED	—
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Fanconi Anemia	—	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

Interventions

Interventions (12)

Intervention	Type	Mapped drug	Match
allogeneic bone marrow transplantation	Procedure	—	UNRESOLVED
anti-thymocyte globulin	Biological	—	UNRESOLVED
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
fludarabine phosphate	Drug	Fludarabine	ALIAS
graft-versus-tumor induction therapy	Biological	—	UNRESOLVED
methylprednisolone	Drug	—	UNRESOLVED
mycophenolate mofetil	Drug	—	UNRESOLVED
peripheral blood stem cell transplantation	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
All patients
description
All patients enrolled on study
interventionNames
1. Biological: anti-thymocyte globulin
2. Biological: graft-versus-tumor induction therapy
3. Biological: sargramostim
4. Biological: therapeutic allogeneic lymphocytes
5. Drug: cyclophosphamide
6. Drug: fludarabine phosphate
7. Drug: methylprednisolone
8. Drug: mycophenolate mofetil
9. Drug: tacrolimus
10. Procedure: allogeneic bone marrow transplantation
11. Procedure: peripheral blood stem cell transplantation
12. Procedure: umbilical cord blood transplantation

Primary outcomes (2)

measure
Day 100 TRM
timeFrame
from start or conditioning (day -6 or -5) through day +100 after HSC infusion
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 4 Years
Maximum age: 75 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of aplastic anemia

  * Severe disease
  * Failed at least 1 course of standard immunosuppressive regimen with cyclosporine and anti-thymocyte globulin OR
* Histologically confirmed hematologic malignancy including the following:

  * Acute leukemia

    * Any of the following types:

      * Acute myeloid leukemia (AML) with antecedent myelodysplastic syndromes
      * Secondary AML
      * AML with high-risk cytogenetic abnormalities
      * Acute lymphoblastic leukemia with high-risk cytogenetic abnormalities
    * Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen OR
    * In first remission at high risk of relapse
  * Chronic myelogenous leukemia

    * Chronic phase meeting at least 1 of the following criteria:

      * Failed imatinib mesylate
      * Failed interferon after at least 6 months of treatment with minimum of 21 million units of interferon per week
      * Unable to tolerate interferon
    * Accelerated phase (blasts less than 20%)
  * Myeloproliferative and myelodysplastic syndromes

    * Myelofibrosis (after splenectomy)
    * Refractory anemia
    * Refractory anemia with excess blasts
    * Chronic myelomonocytic leukemia
  * Lymphoproliferative disease

    * Chronic lymphocytic leukemia

      * Symptomatic disease after first-line chemotherapy
    * Low-grade non-Hodgkin's lymphoma (recurrent or persistent)

      * Symptomatic disease after first-line chemotherapy
    * Multiple myeloma

      * Progressive disease after autologous stem cell transplantation
    * Waldenstrom's macroglobulinemia

      * Failed 1 standard regimen
  * Non-Hodgkin's lymphoma meeting the following criteria:

    * Intermediate or high grade
    * Controlled and chemosensitive disease
    * First remission lymphoblastic or small non-cleaved cell lymphoma at high risk of relapse
  * Hodgkin's lymphoma

    * Relapsed and chemosensitive disease
* Not eligible for standard myeloablative allogeneic stem cell transplantation
* Availability of any of the following donor types:

  * Related donor matched at 5 or 6 HLA antigens (A, B, DR)
  * Unrelated donor fully matched by molecular analysis at A, B, DRB1, and DQB1 loci

    * Single antigen mismatch at C allowed
  * Cord blood that is 4, 5, or 6 match with recipient HLA antigens (A, B, DR) NOTE: No syngeneic donors permitted
* No uncontrolled CNS disease (for hematologic malignancies) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

* 4 to 75 (if related or unrelated donor peripheral blood or marrow transplantation)
* 4 to 60 (if unrelated cord blood transplantation)

Performance status

* Karnofsky \> 50%

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Bilirubin less than 3 times normal
* Alkaline phosphatase less than 3 times normal
* AST/ALT less than 3 times normal
* No Child's class B or C liver failure

Renal

* Creatinine clearance greater than 40 mL/min

Cardiovascular

* Cardiac ventricular ejection fraction at least 35% by MUGA
* No cardiovascular disease

Pulmonary

* DLCO at least 40% of predicted, corrected for hemoglobin and/or alveolar ventilation

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV antibody negative
* No uncontrolled diabetes mellitus
* No active serious infection
* No other disease that would preclude study therapy
* No other concurrent malignancy except non-melanoma skin cancer
* No concurrent serious psychiatric illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* patients may have received a prior autologous blood or marrow transplantation (BMT)
* At least 6 months since prior allogeneic BMT

Chemotherapy

* See Disease Characteristics
* At least 2 weeks since prior chemotherapy, radiation or surgery

Endocrine therapy

* Not specified

Radiotherapy

* At least 2 weeks since prior radiotherapy

Surgery

* At least 2 weeks since prior surgery

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment