Clinical trial · Interventional

Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer

Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States

NCT00002809CI-TRIAL-00003980completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with 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
Myelodysplastic/Myeloproliferative Diseases	Myelodysplastic/Myeloproliferative Neoplasm	ALIAS	0.90
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (9)

Intervention	Type	Mapped drug	Match
allogeneic bone marrow transplantation	Procedure	—	UNRESOLVED
anti-thymocyte globulin	Biological	—	UNRESOLVED
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
methotrexate	Drug	Methotrexate	ALIAS
radiation therapy	Radiation	—	UNRESOLVED
sargramostim	Biological	—	UNRESOLVED
tacrolimus	Drug	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 17 Years
Maximum age: 60 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* One of the following hematologic malignancies/disorders:

  * Acute lymphoblastic leukemia

    * In second or subsequent complete remission (CR)
    * In first CR with high-risk features (e.g., Philadelphia chromosome-positive)
    * In first relapse and failed conventional salvage therapy
  * Acute myelogenous leukemia (AML)

    * In second or subsequent CR
    * In early first relapse
    * In full first relapse and failed conventional salvage therapy
    * In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7

      * Standard-risk AML offered conventional-dose consolidation chemotherapy or autologous bone marrow transplantation
  * Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase

    * No blast crisis
  * Severe aplastic anemia that has failed at least 1 course of immunosuppressive therapy
  * Paroxysmal nocturnal hemoglobinuria with high-risk features (e.g., disseminated intravascular coagulation, thrombotic events)
  * Myelodysplastic syndrome, i.e.:

    * Symptomatic, transfusion-dependent refractory anemia with excess blasts
    * (RAEB) or RAEB in transformation
  * Secondary leukemia in CR following conventional-dose induction chemotherapy
* Unrelated marrow donor available who is 8 out of 10-, 9 out of 10-, or 10 out of 10-antigen serologically HLA-matched at A, B, C, DRb, and DQB loci by molecular typing
* No CNS malignancy

PATIENT CHARACTERISTICS:

Age:

* 17 to 60

Performance status:

* Karnofsky 70-100%

Life expectancy:

* No reduction due to other serious illness

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin less than 3 mg/dL
* AST/ALT no greater than twice normal

Renal:

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

Cardiovascular:

* Left ventricular ejection fraction at least 45%
* No severe hypertension

Pulmonary:

* DLCO, FEV\_1, and FVC at least 50%

Other:

* HIV negative
* No active infection at time of transplant
* No advanced diabetes
* No significant neurologic deficit
* No active drug or substance abuse
* No emotional disorders
* Able to participate in frequent medical care for at least 1-2 years
* Willing to comply with National Marrow Donor Program policies

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

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

Start: Aug 1, 1996
Primary completion: Dec 1, 2003
Completion: Dec 1, 2003
First posted: Jan 27, 2003
Last update posted: Oct 1, 2010
Enrollment: 10 (estimated)
Lead sponsor: Temple University OTHER
Keywords: recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, refractory anemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, secondary acute myeloid leukemia, previously treated myelodysplastic syndromes, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

Data updated 22 days agoSource updated Oct 1, 2010source: clinicaltrials

Locations

Locations by country (1)