Clinical trial · Interventional

Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer

HLA Matched Related and Unrelated Bone Marrow Transplantation With Busulfan/Cyclophosphamide and Post Transplantation Cyclophosphamide for Hematological Malignancies

NCT00134017CI-TRIAL-00034651completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and 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 cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.

Conditions

Conditions (5)

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
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Multiple Myeloma and Plasma Cell Neoplasm	—	UNRESOLVED	—
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Busulfan	Drug	Busulfan	ALIAS
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Bone marrow transplant
description
Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis
interventionNames
1. Drug: Busulfan
2. Drug: Cyclophosphamide

Primary outcomes (1)

measure
Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)
timeFrame
Day 100
description
Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).

Secondary outcomes (4)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 6 Months
Maximum age: 65 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following hematologic malignancies:

  * Acute myeloid leukemia (AML), meeting 1 of the following criteria:

    * AML beyond first complete remission (CR1)
    * Refractory AML
    * AML arising from myelodysplastic syndromes (MDS)
    * Secondary AML
  * MDS

    * Refractory anemia with excess blasts with \> 10% blasts in bone marrow
  * Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:

    * ALL in CR1 with 1 of the following high-risk features:

      * Philadelphia chromosome (Ph)-positive disease
      * Less than 1 year of age at diagnosis
      * Cytogenetic abnormalities involving chromosome 11q23
    * ALL beyond CR1
    * Refractory ALL
  * Chronic myeloid leukemia beyond first chronic phase
  * Chronic myelomonocytic leukemia
  * Chronic lymphocytic leukemia

    * Stage III-IV disease
    * Does not meet criteria for other bone marrow transplantation (BMT) studies
  * Myeloproliferative disorders

    * Ph-negative disease
  * Hodgkin's or non-Hodgkin's lymphoma

    * Chemotherapy-resistant disease
  * Paroxysmal nocturnal hemoglobinuria with life-threatening thrombosis
  * Multiple myeloma

    * Stage II or III disease
* Very high-risk disease

  * Having an unrelated donor is considered a high-risk condition
* Meets medical criteria for myeloablative BMT for the Sidney Kimmel Comprehensive Cancer Center
* Bone marrow donor available, meeting 1 of the following criteria:

  * Genotypically HLA-identical sibling
  * Phenotypically matched first-degree relative
  * Unrelated donor molecularly matched at HLA-A, -B, -C, -DRB1, and -DQB1

PATIENT CHARACTERISTICS:

Age

* 6 months to 65 years

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* See Disease Characteristics

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* No concurrent dexamethasone as an antiemetic during immunosuppression therapy

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No concurrent immunosuppressants until ≥ 24 hours after the completion of cyclophosphamide (post-transplantation)

References

Publications (1)

RESULTLuznik L, Bolanos-Meade J, Zahurak M, Chen AR, Smith BD, Brodsky R, Huff CA, Borrello I, Matsui W, Powell JD, Kasamon Y, Goodman SN, Hess A, Levitsky HI, Ambinder RF, Jones RJ, Fuchs EJ. High-dose cyclophosphamide as single-agent, short-course prophylaxis of graft-versus-host disease. Blood. 2010 Apr 22;115(16):3224-30. doi: 10.1182/blood-2009-11-251595. Epub 2010 Feb 2. PMID 20124511

Registry

Dates and enrollment