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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044954
First Posted: January 27, 2003
Last Update Posted: February 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
September 6, 2002
January 27, 2003
February 9, 2009
November 2001
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Complete list of historical versions of study NCT00044954 on ClinicalTrials.gov Archive Site
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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

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.

OBJECTIVES:

  • Determine the response rate and duration of response in patients with low-risk hematologic malignancies treated with low-dose total-body irradiation (TBI) and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a slow immunosuppression taper and donor leukocyte infusions (DLI).
  • Determine the response rate and duration of response in patients with high-risk hematologic malignancies treated with low-dose TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression taper and DLI.
  • Determine the incidence and extent of graft-versus-host disease, regimen-related toxicity, and engraftment in patients treated with these regimens.
  • Assess the quality of life of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups (high-risk vs low-risk hematologic malignancy). The high-risk group includes acute myelogenous leukemia, myelodysplastic syndromes, accelerated phase chronic myelogenous leukemia (CML), second chronic phase CML, and non-Hodgkin's lymphoma. The low-risk group includes Hodgkin's lymphoma, first chronic phase CML, multiple myeloma, and chronic lymphocytic leukemia.

Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation. Patients also receive oral mycophenolate mofetil on days 0-28.

High-risk patients receive oral cyclosporine twice daily on days -2 to day 60. Patients with persistent disease, T-cell chimerism, and no graft-vs-host disease (GVHD) on day 90 receive up to 3 doses of donor leukocyte infusion (DLI) over the next 4 months.

Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150. Patients with persistent disease, T-cell chimerism, and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months.

Quality of life is assessed at baseline and at 1, 3, 6, 9, 12, 18, and 24 months.

Patients are followed at 1, 3, 6, 9, and 12 months and then annually for 2 years.

PROJECTED ACCRUAL: A total of 120 patients (60 per group) will be accrued for this study.

Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Biological: therapeutic allogeneic lymphocytes
  • Drug: cyclosporine
  • Drug: fludarabine phosphate
  • Drug: mycophenolate mofetil
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00044954
CDR0000069461
UTSMC-0799296
AMGEN-UTSMC-0799296
IBMTR-SC-00-03.1
ROCHE-UTSMC-0799296
SPRI-UTSMC-0799296
NCI-V02-1705
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Simmons Cancer Center
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Study Chair: Robert H. Collins, MD Simmons Cancer Center
National Cancer Institute (NCI)
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP