Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 66 to 74 NCI FHCRC-1209.00 NCI-G97-1359, NCT00003145

Objectives

1. Determine whether mixed hematopoietic chimerism can be safely established with fludarabine, low-dose total body irradiation, and allogeneic peripheral blood stem cell transplantation followed by immunosuppression with cyclosporine and mycophenolate mofetil and donor lymphocyte infusion in older patients with chronic or accelerated phase chronic myelogenous leukemia.
2. Determine whether mixed chimerism can be converted to full donor hematopoietic chimerism with infusions of donor lymphocytes in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed chronic myelogenous leukemia in first or second chronic or first accelerated phase



• Philadelphia chromosome positive



• Must have an HLA genotypically identical related donor (excluding identical twins)



• Not in interferon-induced complete or partial cytogenetic remission



• May be 65 years of age and under only if at high risk of regimen-related toxicity due to pre-existing chronic disease affecting liver, lungs, and heart OR at the discretion of the principal investigator

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• At least 1 month since prior interferon alfa

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Patient Characteristics:

Age:

• See Disease Characteristics
• 66 to 74

Performance status:

• Karnofsky 70-100% (Karnofsky 50-100% for patients age 65 and under)

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• See Disease Characteristics
• Bilirubin no greater than 2 times upper limit of normal (ULN)*
• SGOT and SGPT no greater than 2 times ULN (4 times ULN for patients age 65 and under)*

 [Note: * Unless due to malignancy]

Renal:

• Renal failure allowed

Cardiovascular:

• See Disease Characteristics
• No poorly controlled hypertension
• Ejection fraction at least 40% (for patients with a history of cardiac disease or anthracycline use)
• No history of congestive heart failure (for patients age 65 and under)

Pulmonary:

• See Disease Characteristics
• DLCO at least 50% of predicted
• No severe defects in pulmonary function testing*
• No supplementary continuous oxygen*

 [Note: * For patients age 65 and under]

Other:

• HIV negative
• Not pregnant
• Fertile patients must use effective contraception during and for 12 months after study participation

Expected Enrollment

A total of 20 patients will be accrued for this study within 3 years.

Outcomes

Efficacy and safety of establishing mixed chimerism using a non-lethal conditioning regimen
Success and safety of converting mixed chimerism to full donor chimerism using donor lymphocyte infusions

Outline

This is a pilot, multicenter study.

Patients receive fludarabine IV on days -4 to -2 and low-dose total body irradiation followed by allogeneic peripheral blood stem cell transplantation on day 0. Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper. Patients also receive oral mycophenolate mofetil twice daily on days 0-27.

At least 2 weeks after completion of cyclosporine and mycophenolate mofetil, patients with persistent or progressive disease receive donor lymphocytes IV over 30 minutes. In the absence of active graft-versus-host disease, patients may receive a total of 3 donor lymphocyte infusions at increasing cell doses.

Patients are followed weekly until 90 days after the last donor cell infusion, monthly for 6 months, every 6 months for 2 years, and then annually for 3 years.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Brenda Sandmaier, MD, Protocol chair		Ph: 206-288-1024

Registry Information
Official Title		Induction of Mixed Hematopoietic Chimerism Using Fludarabine, Low-Dose TBI, PBSC Infusion and Post-Transplantation Immunosuppression With Cyclosporine and Mycophenolate Mofetil To Be Folllowed By Donor Lymphocyte Infusion in Older Patients With Chronic Myeloid Leukemia in Chronic and Accelerated Phases: A Multicenter Study
Trial Start Date		1997-11-17
Registered in ClinicalTrials.gov		NCT00003145
Date Submitted to PDQ		1997-11-20
Information Last Verified		2005-08-20
NCI Grant/Contract Number		CA18029, CA78902, CA15704

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