LeukemiaPhase 2NCT00041288
Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL
A Phase 2 study testing therapeutic allogeneic lymphocytes, cyclophosphamide and cyclosporine in people with Leukemia and Lymphoma, run by University of Texas Southwestern Medical Center at 23 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- therapeutic allogeneic lymphocytes, cyclophosphamide and cyclosporine
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Oct 2001to Jan 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia or
- Diagnosis of non-Hodgkin's lymphoma
- Lymphoplasmacytic lymphoma
- Grade I follicular small cleaved cell lymphoma
- Grade II follicular mixed cell lymphoma
- Diffuse small cleaved cell lymphoma
- Small lymphocytic lymphoma
- Relapsed after at least 1 course of prior therapy
- Availability of a 6/6 human leukocyte antigen (HLA) A, B, and DR identical sibling donor
- Nonmyeloablative transplantation candidate
- No clinically significant effusions or ascites that would preclude administration of methotrexate
PATIENT CHARACTERISTICS:
-Age: 18 to 75
Performance status:
- Eastern Cooperative Oncology Group (ECOG) 0-2 OR 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: left ventricular ejection fraction (LVEF) at least 40% on multigated acquisition (MUGA) scan or echocardiogram
- Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO) at least 50% of predicted
OTHER:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled bacterial, viral, fungal, or parasitic infection
- Human Immunodeficiency Virus (HIV)1 and Human Immunodeficiency Virus (HIV)2 negative
- No other active malignancy except basal cell skin cancer
- No recent history of drug or alcohol abuse
- No other primary disease or comorbid illness that would severely limit life expectancy
PRIOR CONCURRENT THERAPY
- Biologic therapy:See Disease Characteristics
- Biologic therapy:Prior autologous bone marrow transplantation allowed if disease has progressed after transplantation
- Biologic therapy:No entry on study as part of a tandem autologous transplantation followed by nonmyeloablative allograft protocol
- Chemotherapy: Not specified
- Endocrine therapy: Not specified
- Radiotherapy:Not specified
- Surgery: Not specified
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States19 sites
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342-1601
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-8590
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
University of Missouri Kansas City School of Medicine
Kansas City, Missouri, 64111
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
Delaware Clinical & Laboratory Physicians
Newark, Delaware, 19713
Florida Hospital Cancer Institute
Orlando, Florida, 32804
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Oregon Cancer Institute
Portland, Oregon, 97239
Massey Cancer Center
Richmond, Virginia, 23298-0037
James P. Wilmot Cancer Center
Rochester, New York, 14642
Texas Transplant Institute
San Antonio, Texas, 78229
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Canada4 sites
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Hopital du Saint-Sacrament, Quebec
Québec, Quebec, G1S 4L8
Princess Margaret Hospital
Toronto, Ontario, M4S 1KN
University of Toronto
Toronto, Ontario, M5S 1A8
About this study
Official title: A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And Chronic Lymphocytic Leukemia (CLL)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may prevent this from happening.
PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES:
- Compare the 1-year overall survival rate of patients with relapsed low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with fludarabine and total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic peripheral blood stem cell transplantation and donor lymphocyte infusions.
- Compare the toxic effects of these regimens in these patients.
- Compare the incidence and severity of acute and chronic graft-versus-host disease in patients treated with these regimens.
- Compare the 1-year treatment-related mortality and infectious complications in patients treated with these regimens.
- Compare the efficacy of these treatment regimens, in terms of 1-year disease-free survival, of these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease, age (less than 55 vs over 55), and participating transplantation center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral mycophenolate mofetil twice daily on days 0-28.
- Arm II: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on days -3 to -2. Patients undergo PBSCT on day 0. Patients receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and tacrolimus IV continuously and then orally on days -2 to 90 followed by a taper on days 90-150.
At approximately day 180, patients with persistent disease, evidence of T-cell chimerism, and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months.
Quality of life is assessed at baseline, 1 month, every 3 months for 1 year, and then every 6 months for 1 year.
Patients are followed at 1 month, every 3 months for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
- Being tested
- therapeutic allogeneic lymphocytes, cyclophosphamide, cyclosporine, fludarabine phosphate, methotrexate
- Keywords
- Waldenstrom macroglobulinemia, refractory chronic lymphocytic leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent small lymphocytic lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Waldenstrom Macroglobulinemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic allogeneic lymphocytesBiological
cyclophosphamideDrug
cyclosporineDrug
methotrexateDrug
tacrolimusDrug
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2001
- Primary completionJan 2003
- Study completionJan 2003
Why it stopped: Poor accrual and difficulty with multicenter logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert H. Collins, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041288
- Sponsor's protocol ID
- CDR0000069462
- Other IDs
- UTSMC-0501228, AMGEN-UTSMC-0501228, IBMTR-SC-00-02.1, ROCHE-UTSMC-0501228, SPRI-UTSMC-0501228, NCI-V02-1706
- Status last verified
- Apr 2020
- First submitted
- 8 Jul 2002
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT00041288
- Acronym / sponsor ID
- CDR0000069462
- Keywords
- Waldenstrom macroglobulinemia, refractory chronic lymphocytic leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent small lymphocytic lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual and difficulty with multicenter logistics
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may prevent this from happening.
PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Detailed description
OBJECTIVES:
- Compare the 1-year overall survival rate of patients with relapsed low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with fludarabine and total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic peripheral blood stem cell transplantation and donor lymphocyte infusions.
- Compare the toxic effects of these regimens in these patients.
- Compare the incidence and severity of acute and chronic graft-versus-host disease in patients treated with these regimens.
- Compare the 1-year treatment-related mortality and infectious complications in patients treated with these regimens.
- Compare the efficacy of these treatment regimens, in terms of 1-year disease-free survival, of these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease, age (less than 55 vs over 55), and participating transplantation center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral mycophenolate mofetil twice daily on days 0-28.
- Arm II: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on days -3 to -2. Patients undergo PBSCT on day 0. Patients receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and tacrolimus IV continuously and then orally on days -2 to 90 followed by a taper on days 90-150.
At approximately day 180, patients with persistent disease, evidence of T-cell chimerism, and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months.
Quality of life is assessed at baseline, 1 month, every 3 months for 1 year, and then every 6 months for 1 year.
Patients are followed at 1 month, every 3 months for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic allogeneic lymphocytes | Biological | – |
| cyclophosphamide | Drug | – |
| cyclosporine | Drug | – |
| fludarabine phosphate | Drug | – |
| methotrexate | Drug | – |
| mycophenolate mofetil | Drug | – |
| tacrolimus | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Poor accrual and difficulty with multicenter logistics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H. Collins, MD study chair
Simmons Cancer Center
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing therapeutic allogeneic lymphocytes, cyclophosphamide and cyclosporine in people with Leukemia and Lymphoma, run by University of Texas Southwestern Medical Center at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor accrual and difficulty with multicenter logistics). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.