Clinical trial · Observational

Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation

NCT00008216CI-TRIAL-00014793terminatedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Poor enrollment

Summary

Brief summary (as posted)

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor peripheral blood stem cell 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 the effectiveness of donor peripheral blood stem cell transplant in treating patients with hematologic cancer.

Conditions

Conditions (7)

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

Condition (as posted)	Mapped entity	Match	Confidence
Adult Langerhans Cell Histiocytosis	Adult Langerhans Cell Histiocytosis	ONTOLOGY_EXACT	0.98
Childhood Langerhans Cell Histiocytosis	Childhood Langerhans Cell Histiocytosis	ONTOLOGY_EXACT	0.98
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Multiple Myeloma and Plasma Cell Neoplasm	—	UNRESOLVED	—
Myelodysplastic/Myeloproliferative Neoplasms	Myelodysplastic/Myeloproliferative Neoplasm	CURATED_BROADER	0.80
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Peripheral Blood Stem Cell Transplantation	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
alloSCT group
description
Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).
interventionNames
1. Procedure: Peripheral Blood Stem Cell Transplantation

Primary outcomes (2)

measure
Toxicity
timeFrame
6 months
description
Number of irreversible severe (grade 3) or life-threatening or lethal (grade 4-5) organ toxicities.
measure
Time to engraftment
timeFrame
6 months
description
Days from infusion of stem cells to recovery of PMN \> 500/ul for two consecutive determinations, transfusion independence for platelets (\>20,000/ul) and RBCs (Hct \> 25%). The bone marrow function is considered durable if reconstitution persists for at least 6 months.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 65 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of one of the following:

  * Chronic myelogenous leukemia

    * Philadelphia chromosome-positive OR
    * Molecular evidence of bcr/abl gene rearrangement
  * Acute myeloid leukemia, acute lymphocytic leukemia, lymphoma, histiocytoses, myelodysplasia, juvenile chronic myelomonocytic leukemia, aplastic anemia, paroxysmal nocturnal hemoglobinuria, or Fanconi's anemia

    * Confirmed by cytochemistry, immunophenotyping, and/or chromosomal abnormalities
  * Multiple myeloma
  * Hereditary immunodeficiency disorders

    * Confirmed by immunologic determination
  * Sickle cell anemia or beta-thalassemia

    * Confirmed by hemoglobin electrophoresis
  * Storage disorders (e.g., Gaucher's disease, Hurler's disease, or metachromatic leukodystrophy)

    * Confirmed by metabolic testing
  * Other non-malignant conditions
* Eligible for allogeneic peripheral blood stem cell or bone marrow transplantation

PATIENT CHARACTERISTICS:

Age:

* 65 and under

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

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