Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer

NCT00818961 | Terminated Phase 2 Results

• 2 other identifiers: CDR0000630617BMTGG-NSH-756
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, such as alemtuzumab, before transplant and tacrolimus and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of donor stem cell transplant and to see how well it works in treating patients with high-risk hematologic cancer.

Conditions

Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases

Keywords

accelerated phase chronic myelogenous leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission; adult AML with 11q23 (MLL) abnormalities; blastic phase chronic myelogenous leukemia; chronic myelomonocytic leukemia; chronic phase chronic myelogenous leukemia; prolymphocytic leukemia; recurrent adult T-cell leukemia/lymphoma; refractory chronic lymphocytic leukemia; relapsing chronic myelogenous leukemia; secondary acute myeloid leukemia; stage I adult T-cell leukemia/lymphoma; stage I chronic lymphocytic leukemia; stage II adult T-cell leukemia/lymphoma; stage II chronic lymphocytic leukemia; stage III adult T-cell leukemia/lymphoma; stage III chronic lymphocytic leukemia; stage IV adult T-cell leukemia/lymphoma; stage IV chronic lymphocytic leukemia; recurrent adult Hodgkin lymphoma; anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; cutaneous B-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell NHL; stage I cutaneous T-cell NHL; stage II cutaneous T-cell NHL; stage III cutaneous T-cell NHL; stage IV cutaneous T-cell NHL; extranodal marginal zone B-cell lymphoma of mucosal tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; contiguous st II adult diffuse large cell lymphoma; contiguous st II adult diffuse mixed cell lymphoma; contiguous st II adult diffuse sm cleaved cell lymphoma; contiguous st II grade 1 follicular lymphoma; contiguous st II grade 2 follicular lymphoma; contiguous st II grade 3 follicular lymphoma; contiguous st II mantle cell lymphoma; contiguous st II marginal zone lymphoma; contiguous st II small lymphocytic lymphoma; stage I adult diffuse large cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse small cleaved cell lymphoma; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage I mantle cell lymphoma; stage I marginal zone lymphoma; stage I small lymphocytic lymphoma; noncontiguous st II adult diffuse large cell lymphoma; noncontiguous st II adult diffuse mixed cell lymphoma; noncontiguous st II adult diffuse sm cleaved cell lymphoma; noncontiguous st II grade 1 follicular lymphoma; noncontiguous st II grade 2 follicular lymphoma; noncontiguous st II grade 3 follicular lymphoma; noncontiguous st II mantle cell lymphoma; noncontiguous st II marginal zone lymphoma; noncontiguous st II small lymphocytic lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III mantle cell lymphoma; stage III marginal zone lymphoma; stage III small lymphocytic lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV mantle cell lymphoma; stage IV marginal zone lymphoma; stage IV small lymphocytic lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult gr III lymphomatoid granulomatosis; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; de novo MDS; previously treated MDS; secondary myelodysplastic syndromes; Waldenstrom macroglobulinemia; myelodysplastic/myeloproliferative disease

Outcome Measures

Primary Outcomes (1)

• Survival at Day 100

  Survival at Day 100

  100 day

Secondary Outcomes (10)

• Overall Survival at 1 Year

  1 year

• Non-relapse Mortality at Day 100

  Day 100

• Non-relapse Mortality at 1 Year Post-transplant

  1 year

• Complete Donor Chimerism

  2 years

• Neutrophil Recovery

  Day 100

Study Arms (1)

Hematopoietic Stem Cell Transplantation

OTHER

All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on donor type

Biological: alemtuzumab; Biological: graft-versus-tumor induction therapy; Biological: rituximab; Drug: busulfan; Drug: cyclophosphamide; Drug: fludarabine phosphate; Drug: methotrexate; Drug: tacrolimus; Procedure: allogeneic bone marrow transplantation

Interventions

alemtuzumab BIOLOGICAL

43 mg subcutaneously over 3 days (3 mg on day -11, 10 mg on day -10, 30 mg on day -9)

Also known as: Campath

Hematopoietic Stem Cell Transplantation

graft-versus-tumor induction therapy BIOLOGICAL

curative potential of allogeneic transplant results from the immune anti-tumor effect of donor cells or GVT/GVL

Hematopoietic Stem Cell Transplantation

rituximab BIOLOGICAL

in patients with Cd20+ malignancies: rituximab 375 mg/m\*2 day -13. rituximab 1000 mg/m\*2 on days, -6, +1, +8.

Also known as: Rituxan

Hematopoietic Stem Cell Transplantation

busulfan DRUG

For patients with AML, CML, MDS, MPS and ALL only: IV or oral busulfan may be given IV busulfan: 130 mg/m2 over 3 hours once daily on days -6, -5, -4 and -3 Oral busulfan: taken every 6 hours x 15 doses beginning on day -7 at 6pm and continuing through day -3 at 6am. 1 mg/kg test dose will be given prior to day -7 and PK samples will be drawn to calculate AUC.

Hematopoietic Stem Cell Transplantation

cyclophosphamide DRUG

750 mg/m2 infused over 1 hour once daily on days -5, -4 and -3. Cyclophosphamide will be started approximately 4 hours after the start of Fludarabine

Also known as: Cytoxan

Hematopoietic Stem Cell Transplantation

fludarabine phosphate DRUG

For patients with CLL, NHL \& HD: 30 mg/m2 infused over 30 minutes once daily on days -5, -4 and -3 For patients with AML, CML, MDS, MPS and ALL: 40 mg/m2 infused over 30 minutes once daily on days -6, -5, -4 and -3.

Also known as: Fludara

Hematopoietic Stem Cell Transplantation

methotrexate DRUG

5 mg/m2 administered on days +1, +3 and +6

Hematopoietic Stem Cell Transplantation

tacrolimus DRUG

0.03mg/kg/day infused over 24 hours starting on day -1 and switched to oral (twice daily divided dose) on day 14 or when able to tolerate PO

Also known as: Prograf; FK506

Hematopoietic Stem Cell Transplantation

allogeneic bone marrow transplantation PROCEDURE

Recipients will receive an allogeneic transplant on day 0 after receiving high-dose chemotherapy. This trial uses matched unrelated donor stem cells.

Also known as: HSCT, allo transplant

Hematopoietic Stem Cell Transplantation

Eligibility Criteria

• Age: 40 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Diagnosis of one of the following hematological malignancies: * CML, with 1 of the following: * In first CP AND failed imatinib mesylate therapy, defined as failure to obtain a hematologic remission at 3 months or a major cytogenetic response (i.e., Ph+ cells \< 35%) at 6 months or demonstrated clonal evolution or disease progression during therapy * In accelerated phase with \< 15% blasts * In blast crisis that has entered into a second CP following induction chemotherapy * AML, with 1 of the following: * In second or subsequent complete remission (CR) (i.e., \< 5% blasts by morphology, no residual leukemia by flow cytometry, and absence of cytogenetic abnormalities) * Failed primary induction chemotherapy, but subsequently entered into a CR with ≤ 2 subsequent re-induction chemotherapy treatment(s) * In first CR with intermediate-risk or poor-risk cytogenetics * ALL with 1 of the following: * In second or subsequent CR * In first CR AND presence of t(9;22) * MDS, with the following: * High-risk disease, defined by IPSS score of ≥ 1.5 at diagnosis AND meets 1 of the following criteria: * ≤ 10% blasts at diagnosis * In morphologic CR (\< 5% blasts) following cytoreductive chemotherapy * CMML, with 1 of the following: * ≤ 10% blasts at diagnosis * In morphologic CR (\< 5% blasts) following cytoreductive chemotherapy * CLL/PLL with the following: * Rai stage I-IV disease * Failed ≥ 1 prior chemotherapy regimen (including fludarabine phosphate) or ASCT * Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as \< 20% bone marrow involvement AND lymph node size \< 3 cm in axial diameter * No bulky tumor masses, elevated lactate dehydrogenase (LDH), B symptoms, or progressive disease prior to transplant * Low-grade non-Hodgkin lymphoma (NHL) (i.e., small lymphocytic lymphoma, follicular center lymphoma \[grade 1 or 2\], marginal zone lymphoma, or B-cell lymphoma), with the following criteria: * Failed ≥ 1 prior chemotherapy regimen or ASCT * Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as \< 20% bone marrow involvement AND lymph node size \< 3 cm in axial diameter * Received ≤ 3 prior chemotherapy regimens (monoclonal antibody therapy and involved-field radiotherapy are not considered a prior regimen) * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Mantle cell lymphoma, with the following: * Failed to achieve remission or recurred after either conventional chemotherapy or ASCT * Responsive or stable disease to most recent prior therapy * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Intermediate-grade NHL (i.e., follicular center lymphoma \[grade 3\] or diffuse large cell lymphoma), meeting the following criteria: * Failed to achieve remission or recurred after either conventional chemotherapy or ASCT * Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites) * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Hodgkin lymphoma, with the following: * Relapsed after prior ASCT OR after ≥ 2 combination chemotherapy regimens and ineligible for ASCT * Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites) * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Peripheral T-cell NHL, with the following: * Failed to achieve remission or recurred after either conventional chemotherapy or ASCT * Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites) * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Myeloproliferative syndrome with poor risk features, meeting 1 of the following criteria: * \< 55 years old AND Lille score of 1 * Lille score of 2 * HgB \< 10 g/dL AND abnormal karyotype * High-risk disease, with 1 of the following: * Age 40-72 years * Any age AND deemed to be at significantly increased risk of morbidity and death following a standard, myeloablative unrelated donor stem cell transplant (e.g., received extensive prior therapy, including ASCT) * HLA-matched unrelated donor available, with 1 of the following: * 8/8 match at HLA-A, B, C, or DR loci by high-resolution genotyping * Single allelic mismatch at either the HLA-B or HLA-C loci donor by high-resolution molecular typing * No single allelic mismatch at HLA-A or HLA-DR loci * KPS 80-100% * Adapted weighted Charlson Comorbidity Index \< 3 * Serum creatinine ≤ 2.0 mg/dL * AST or ALT \< 3 times upper limit of normal (ULN) * Total bilirubin \< 1.5 times ULN * LVEF ≥ 45% * DLCO \> 50% * No hypoxia at rest with oxygen saturation \< 92% on room air (corrected with bronchodilator therapy) * No other severe pulmonary function abnormalities * No HIV infection * No active hepatitis B or C infection that, in the opinion of a gastroenterologist or the transplant committee, places the patient at moderate to high risk for developing severe hepatic disease * No active opportunistic infection (e.g., fungal pneumonia, tuberculosis, or viral infection)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northside Hospital, Inc.: lead
• Blood and Marrow Transplant Group of Georgia: collaborator

Study Sites (1)

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myeloid, Accelerated Phase; Congenital Abnormalities; Blast Crisis; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Chronic-Phase; Leukemia, Prolymphocytic; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic; Immunoblastic Lymphadenopathy; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Waldenstrom Macroglobulinemia

Interventions

Alemtuzumab; Rituximab; Busulfan; Cyclophosphamide; fludarabine phosphate; Methotrexate; Tacrolimus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, B-Cell; Lymphoma, T-Cell; Lymphadenopathy; Lymphoma, B-Cell; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Lactones

Results Point of Contact

• Title: Scott R. Solomon, MD
• Organization: Blood and Marrow Transplant Group of Georgia

ssolomon@bmtga.com

404-255-1930

Study Officials

• Scott R. Solomon, MD

  Blood and Marrow Transplant Group of Georgia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: May 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: December 18, 2013
• Results First Posted: December 18, 2013

Record last verified: 2013-10

Locations

US (1)