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Donor Peripheral Stem Cell Transplant in Treating Older Patients With Hematologic Cancer
This study is ongoing, but not recruiting participants.
Study NCT00025662   Information provided by National Cancer Institute (NCI)
First Received: October 11, 2001   Last Updated: February 6, 2009   History of Changes

October 11, 2001
February 6, 2009
May 2001
 
Treatment-related mortality at 100 days [ Designated as safety issue: No ]
Treatment-related mortality at 100 days
Complete list of historical versions of study NCT00025662 on ClinicalTrials.gov Archive Site
  • Incidence of chronic graft-vs-host disease [ Designated as safety issue: No ]
  • Long-term disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Incidence of chronic graft-vs-host disease
  • Long-term disease-free survival
  • Overall survival
 
Donor Peripheral Stem Cell Transplant in Treating Older Patients With Hematologic Cancer
Ex Vivo Selective Depletion of Alloreactive Donor T Lymphocytes Utilizing RFT5-SMPT-dgA, a Specific Anti-Interleukin-2 Receptor Immunotoxin: Reducing Graft-Versus-Host Disease Risk Associated With HLA-Matched, Nonmyeloablative, Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies in Older Adults

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and removing the T cells from the donor cells before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well fludarabine, melphalan, and donor peripheral stem cell transplant followed by cyclosporin work in treating older patients with hematologic cancer.

OBJECTIVES:

  • Determine the toxicity and efficacy of peripheral blood stem cell transplantation comprising selectively depleted donor T lymphocytes in older patients with hematologic malignancies.
  • Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
  • Determine the engraftment kinetics and incidence of graft failure in patients treated with this regimen.
  • Determine the rates of transplant-related mortality, relapse, and disease-free and overall survival in patients treated with this regimen.

OUTLINE: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. Patients undergo infusion of allogeneic T-cell-depleted and CD34-enriched peripheral blood stem cells and selectively depleted lymphocytes on day 0.

Patients also receive cyclosporine orally or IV on days -4 to 100 as graft-versus-host disease prophylaxis. Patients may receive unmanipulated or selectively depleted donor lymphocytes on day 100.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 15-28 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Biological: therapeutic allogeneic lymphocytes
  • Drug: cyclosporine
  • Drug: fludarabine phosphate
  • Drug: melphalan
  • Procedure: in vitro-treated peripheral blood stem cell transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
28
 
 

DISEASE CHARACTERISTICS:

  • One of the following diagnoses:

    • Chronic myelogenous leukemia in chronic or accelerated phase that has relapsed after therapy with imatinib mesylate
    • Acute lymphoblastic leukemia (ALL) in complete remission (CR) or partial remission (PR)

      • No T-cell ALL
    • Acute myelogenous leukemia (AML) in first CR or PR, including AML secondary to prior chemotherapy or prior hematologic disease (e.g., myelodysplastic syndrome [MDS] or myeloproliferative disorder) or AML in second or subsequent CR

      • No AML with good-risk karyotypes: AML M3 t(5;17), AML M4Eo (inv.16), or AML t(8;21)
    • MDS, including any of the following:

      • Refractory anemia with excess blasts (RAEB)
      • RAEB in transformation
      • MDS with poor-risk cytogenetics
      • MDS secondary to prior cytotoxic therapy or radiotherapy
      • Chronic myelomonocytic leukemia
    • Chronic lymphoblastic leukemia or prolymphocytic leukemia

      • Refractory to nucleoside analog therapy
      • Progressive bulky disease OR
      • Anemia (hemoglobin less than 10 g/dL) or thrombocytopenia (less than 100,000/mm^3) not due to recent chemotherapy
    • Mantle cell lymphoma
    • Intermediate- or high-grade non-Hodgkin's lymphoma (NHL)

      • Relapsed after autologous bone marrow transplantation (AuBMT) or peripheral blood stem cell transplantation (PBSCT) OR
      • Chemorefractory relapse
      • No T-cell NHL
    • Hodgkin's lymphoma meeting one of the following criteria:

      • Relapsed after AuBMT or PBSCT
      • Chemorefractory relapse
    • Low-grade follicular or small lymphocytic lymphoma meeting one of the following criteria:

      • Relapsed after conventional chemotherapy
      • Relapsed after AuBMT or PBSCT
      • Chemoresistant disease
  • Must have an HLA-identical family donor

    • 18 to 75 years of age NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

  • 50 to 75

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • See Disease Characteristics
  • Absolute lymphocyte count at least 1,500/mm^3

Hepatic:

  • Bilirubin no greater than 4 mg/dL
  • Transaminases no greater than 5 times upper limit of normal

Renal:

  • Creatinine no greater than 2.5 mg/dL

Cardiovascular:

  • LVEF at least 40% of predicted

Pulmonary:

  • DLCO at least 60% of predicted

Other:

  • HIV negative
  • No other malignancy that is likely to relapse or progress within 2 years
  • No other major anticipated illness or organ failure
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00025662
 
CDR0000068983, NHLBI-01-H-0162, NCI-5783
National Heart, Lung, and Blood Institute (NHLBI)
 
Study Chair: Austin J. Barrett, MD, FRCP NHLBI - Bone Marrow Transplantation Unit
National Cancer Institute (NCI)
November 2006

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