Clinical trial · Interventional

Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Low Dose Total-Body Irradiation And Fludarabine Followed By HLA Matched Allogeneic Stem Cell Transplantation For Hematologic Malgnancies - A Multi-Center Study

NCT00044954CI-TRIAL-00040659completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have 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
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	0.90

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
allogeneic bone marrow transplantation	Procedure	—	UNRESOLVED
cyclosporine	Drug	—	UNRESOLVED
fludarabine phosphate	Drug	Fludarabine	ALIAS
mycophenolate mofetil	Drug	—	UNRESOLVED
peripheral blood stem cell transplantation	Procedure	—	UNRESOLVED
radiation therapy	Radiation	—	UNRESOLVED
therapeutic allogeneic lymphocytes	Biological	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of one of the following hematologic malignancies:

  * Chronic myelogenous leukemia (CML)

    * First or second chronic phase
    * Accelerated phase
  * Acute myelogenous leukemia (AML)

    * At least second remission
    * First remission allowed if poor-risk features are present (complex chromosome karyotype, abnormalities of chromosomes, especially 5 or 7, 12p-, +13, +8, t\[9:11\])
  * Myelodysplastic syndromes (MDS)

    * Intermediate- or high-risk disease by the prognostic scoring system
  * Multiple myeloma (MM)
  * Hodgkin's lymphoma

    * Second or greater relapse
    * First relapse allowed if disease-free interval is less than 1 year
    * Ineligible for autologous transplantation
  * Non-Hodgkin's lymphoma (NHL)

    * Grade III follicular large cell (relapsed after one course of prior chemotherapy)
    * Diffuse large cell (relapsed after one course of prior chemotherapy)
    * Mantle cell
  * Chronic lymphocytic leukemia (CLL)

    * Relapsed after at least 1 course of prior therapy
* Must have 6 out of 6 HLA A-, B-, and DR- identical sibling donor

PATIENT CHARACTERISTICS:

Age

* 18 to 75 for patients with MM
* 50 to 75 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL
* 18 to 49 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL who are considered eligible for an allogeneic bone marrow transplantation (BMT) but do not meet institutional criteria for a standard allogeneic BMT

Performance status

* Zubrod 0-2

Life expectancy

* At least 6 months

Hematopoietic

* Not specified

Hepatic

* Bilirubin no greater than 3 mg/dL

Renal

* Creatinine no greater than 2 mg/dL

Cardiovascular

* LVEF at least 40% by MUGA or echocardiogram

Pulmonary

* DLCO at least 50% of predicted

Other

* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No recent history of drug or alcohol abuse
* No other prior malignancy except basal cell skin cancer
* No uncontrolled bacterial, viral, fungal, or parasitic infections

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Prior autologous transplantation allowed if disease progression occurred
* No prior or concurrent tandem autologous transplantation followed by non-myeloablative-allograft protocol

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: Nov 1, 1999
Primary completion: Nov 1, 2006
Completion: Nov 1, 2006
First posted: Jan 27, 2003
Last update posted: Sep 17, 2019
Lead sponsor: University of Texas Southwestern Medical Center OTHER
Keywords: recurrent adult Hodgkin lymphoma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, recurrent mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, refractory multiple myeloma, stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, refractory chronic lymphocytic leukemia, 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 Sep 17, 2019source: clinicaltrials

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