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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-109901 | |||
| CDR0000068185 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, 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 how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 to 2 hours on days -5 to -3. Patients undergo allogeneic peripheral blood stem cell transplantation on days 0-1. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover.
Patients with no signs of active graft-versus host disease and stable or progressive disease receive donor lymphocytes IV over 2 hours beginning after day 120. Patients may receive a total of 3 infusions at least 8 weeks apart if disease remains stable or progressive.
Patients are followed every 3 months for 2 years and then every 6 months for 5 years.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic Stem Cell Tx | Experimental | minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fludarabine phosphate | Drug | 30 mg/sq m/day IV infusion for 5 days (Days -7 thru -3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related mortality within the first 6 months post-transplant | 6 months post chemo initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Response | 6 months & 12 months | |
| Percentage of patients achieving complete donor chimerism or mixed donor chimerism | 90 days post transplant | |
| Survival |
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DISEASE CHARACTERISTICS:
One of the following histologically confirmed diagnoses:
Chronic lymphocytic leukemia
Absolute lymphocytosis greater than 5,000/mm^3
Morphologically mature lymphocytes with less than 55% prolymphocytes
Lymphocyte phenotypic expression of CD19 and CD5
Failed at least 1 prior regimen
At least 1 of the following high-risk factors and not in first complete remission
= 17p deletion = 11q deletion
Unmutated VH gene status
p53 mutations
Prolymphocytic leukemia (PLL)
Low-grade non-Hodgkin's lymphoma
Over 60 years of age
Performance status greater than 1
LDH greater than normal
More than 1 site of extranodal disease
Disease stage III or IV
Mantle cell lymphoma
Immunophenotypic expression of CD5 and CD19 and absence of CD23
Cytogenetic analysis with presence of t(11;14)
Overexpression of cyclin D1
Rearrangement of BCL1 gene
Responsive or stable disease to most recent prior therapy
Must have HLA identical sibling (6/6) donor by serologic typing (A, B, DR)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Shea, MD | UNC Lineberger Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rebecca and John Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States | ||
| Veterans Affairs Medical Center - San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21296675 | Result | Shea T, Johnson J, Westervelt P, Farag S, McCarty J, Bashey A, Isola L, Baxter-Lowe LA, Kelly M, Owzar K, Linker C; Cancer and Leukemia Group B. Reduced-intensity allogeneic transplantation provides high event-free and overall survival in patients with advanced indolent B cell malignancies: CALGB 109901. Biol Blood Marrow Transplant. 2011 Sep;17(9):1395-403. doi: 10.1016/j.bbmt.2011.01.016. Epub 2011 Feb 3. |
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| Cyclophosphamide | Drug | 1 g/sq m/day IV infusion x 3 days (Days -5 thru -3) |
|
| PBSC | Biological | 2-8,000,000/kg CD34+ cells via infusion on Day 0 |
|
| G-CSF | Drug | 5 ug/kg/day subQ injection until ANC > 1000/uL for 3 days beginning Day 5 |
|
| Donor lymphocytes | Biological | 10,000,000 CD3+ cells/kg via infusion |
|
Disease free and overall survival will be assessed |
| 5 years post study entry |
| San Diego |
| California |
| 92161 |
| United States |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| St. Francis Hospital | Wilmington | Delaware | 19805 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242 | United States |
| Union Hospital Cancer Center at Union Hospital | Elkton MD | Maryland | 21921 | United States |
| UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Elmhurst Hospital Center | Elmhurst | New York | 11373 | United States |
| Queens Cancer Center of Queens Hospital | Jamaica | New York | 11432 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224-1791 | United States |
| Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia | 23298-0037 | United States |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| D008228 | Lymphoma, Non-Hodgkin |
| D015463 | Leukemia, Prolymphocytic |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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