Clinical trial · Interventional

Bone Marrow Transplant in Treating Patients With Hematologic Cancers

Allogeneic Bone Marrow Transplantation for Hematologic Malignancies: A Treatment Approach Based on Risk of Relapse and Toxicity

NCT00005797CI-TRIAL-00048788completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer 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. PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with hematologic cancers.

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
Multiple Myeloma and Malignant Plasma Cell Neoplasms	—	UNRESOLVED	—
Myelodysplastic/Myeloproliferative Neoplasms	Myelodysplastic/Myeloproliferative Neoplasm	CURATED_BROADER	0.80
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
busulfan	Drug	Busulfan	ALIAS
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Fractionated Total Body Irradiation (FTBI)	Radiation	—	UNRESOLVED
VP-16	Drug	Etoposide	ALIAS

Design

Arms and outcomes

Arms (2)

type
OTHER
label
BuCy2
description
Busulfan \& Cyclophosphamide
interventionNames
1. Drug: busulfan
2. Drug: Cyclophosphamide
type
OTHER
label
VP16/TBI
description
Fractionated Total Body Irradiation + VP-16
interventionNames
1. Drug: VP-16
2. Radiation: Fractionated Total Body Irradiation (FTBI)

Primary outcomes (1)

measure
Relapse-free survival
timeFrame
5 years post transplant

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 15 Years
Maximum age: 55 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of:

  * Acute myelogenous leukemia

    * Complete remission (CR) 1 - ALL except good cytogenetics defined as \[(inv16, t(8,21), t(15,17)\]
    * CR2
    * Induction failures
    * Relapsed OR
  * Acute lymphocytic leukemia (ALL)

    * CR1 - high risk defined as overt CNS involvement, 1 or more risk factors (age 30 and over, WBC at least 20,000/mm\^3, at least 4 weeks to CR1, myeloid phenotype)
    * CR2
    * Induction failures
    * Relapsed OR
  * Chronic myelogenous leukemia

    * Chronic phase (CP) 1
    * Accelerated phase (AP)/CP2 OR
  * Chronic lymphocytic leukemia

    * At diagnosis - RAI stage III/IV or Binet C

      * Must undergo 1 induction regimen
    * Relapsed - any stage

      * Must have received no more than 3 regimens for diagnosis OR
  * Multiple myeloma

    * At diagnosis - stage II/III (primary refractory or sensitive)
    * Relapsed no more than 2 times - sensitive disease
    * Plasma cell leukemia OR
  * Myelodysplasia

    * All subtypes eligible OR
  * Myeloproliferative disorders

    * Poor response to medical therapy OR
    * Cytogenetic abnormalities
* Must have a related donor who is genotypic 6 out of 6 HLA A, B, and DR match

  * Molecular DR matching required

PATIENT CHARACTERISTICS:

Age:

* 15 to 55

Performance status:

* Karnofsky 80-100%

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Bilirubin no greater than 2.0 mg/dL
* SGOT/SGPT no greater than 3 times upper limit of normal
* PT/PTT normal

Renal:

* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* LVEF at least 45% by MUGA scan or echocardiography
* No myocardial infarction within the past 6 months
* No arrhythmias controlled by therapy

Pulmonary:

* FEV\_1 at least 50% predicted
* DLCO at least 50% predicted

Other:

* Not pregnant or nursing
* Negative pregnancy test
* No diabetes mellitus or thyroid disease that is not medically controlled
* No psychosocial disorder that would preclude study compliance
* No active serious infections
* HIV negative
* Donor must be HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment