LeukemiaPhase 2NCT00002844
Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
A Phase 2 study testing Cyclophosphamide, Allogeneic Bone Marrow Transplantation and Autologous Bone Marrow Transplantation in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Cyclophosphamide, Allogeneic Bone Marrow Transplantation and Autologous Bone Marrow Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 1991to 5 Jun 2002
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Chronic lymphocytic leukemia (CLL) patients after initial relapse who have achieved a complete or partial remission with fludarabine therapy or after initial relapse or progression Prolymphocytic leukemia in first remission or after relapse Patients 15-65 years old who lack an HLA-identical sibling are eligible for autologous BM transplantation Patients 16-50 years old with an HLA identical or one antigen mismatched related donor are eligible for allogeneic BM transplantation
PATIENT CHARACTERISTICS: Age: 15-65 (See Disease Characteristics) Performance status: Zubrod no more than 2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: DLCO at least 50% of predicted Other: No severe concomitant medical or psychiatric illnesses
PRIOR CONCURRENT THERAPY: No extensive prior radiotherapy which would prevent administration of total body radiation Patients may also participate in study MDA-DM-92082 for retroviral gene marking of the autologous marrow and blood cells
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Bone Marrow Transplantation for Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES: Examine the potential role for high dose cyclophosphamide, total body irradiation and bone marrow transplantation for patients with chronic lymphocytic leukemia who are at high risk for disease progression.
OUTLINE: Patients receive daily intravenous infusions of cyclophosphamide for two days, followed by total body irradiation in four daily exposures. After completion of the total body irradiation, allogeneic or autologous bone marrow is infused intravenously.
PROJECTED ACCRUAL: 50 patients are expected to be accrued.
- Conditions
- Leukemia
- Being tested
- Cyclophosphamide, Allogeneic Bone Marrow Transplantation, Autologous Bone Marrow Transplantation, Total Body Irradiation (TBI)
- Keywords
- refractory chronic lymphocytic leukemia, Cyclophosphamide, Cytoxan, Neosar, Bone Marrow Transplantation, total body irradiation, chronic lymphocytic leukemia, allogeneic, autologous
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan, Neosar
Daily intravenous infusions of cyclophosphamide for two days,
Allogeneic Bone Marrow TransplantationProcedure or surgery
Also called Stem Cell Transplant
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Autologous Bone Marrow TransplantationProcedure or surgery
Also called Stem Cell Transplant
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Total Body Irradiation (TBI)Radiation
Also called radiation therapy
Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide + TBI + BMT | Experimental | TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow) Receives: Drug: Cyclophosphamide; Procedure: Allogeneic Bone Marrow Transplantation; Procedure: Autologous Bone Marrow Transplantation; Radiation: Total Body Irradiation (TBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2004 (estimated)
- Study start5 Mar 1991
- Primary completion5 Jun 2002
- Study completion5 Jun 2002
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 M.D. Anderson Cancer 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard E. Champlin, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002844
- Sponsor's protocol ID
- DM90-106
- Other IDs
- P30CA016672, MDA-DM-90106, NCI-G96-1034, CDR0000065081
- Status last verified
- Oct 2018
- First submitted
- 1 Nov 1999
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Transplantation for Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00002844
- Acronym / sponsor ID
- DM90-106
- Conditions
- Leukemia
- Keywords
- refractory chronic lymphocytic leukemia, Cyclophosphamide, Cytoxan, Neosar, Bone Marrow Transplantation, total body irradiation, chronic lymphocytic leukemia, allogeneic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Mar 1991
- Primary completion
- 5 Jun 2002 (actual)
- Study completion
- 5 Jun 2002 (actual)
- First posted
- 23 Jun 2004 (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 cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with chronic lymphocytic leukemia.
Detailed description
OBJECTIVES: Examine the potential role for high dose cyclophosphamide, total body irradiation and bone marrow transplantation for patients with chronic lymphocytic leukemia who are at high risk for disease progression.
OUTLINE: Patients receive daily intravenous infusions of cyclophosphamide for two days, followed by total body irradiation in four daily exposures. After completion of the total body irradiation, allogeneic or autologous bone marrow is infused intravenously.
PROJECTED ACCRUAL: 50 patients are expected to be accrued.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide + TBI + BMT | Experimental | Drug: Cyclophosphamide, Procedure: Allogeneic Bone Marrow Transplantation, Procedure: Autologous Bone Marrow Transplantation, Radiation: Total Body Irradiation (TBI)TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow) |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| CyclophosphamideAlso: Cytoxan, NeosarDaily intravenous infusions of cyclophosphamide for two days, | Drug | Cyclophosphamide + TBI + BMT |
| Allogeneic Bone Marrow TransplantationAlso: Stem Cell TransplantAfter completion of the TBI, allogeneic or autologous bone marrow infused intravenously. | Procedure or surgery | Cyclophosphamide + TBI + BMT |
| Autologous Bone Marrow TransplantationAlso: Stem Cell TransplantAfter completion of the TBI, allogeneic or autologous bone marrow infused intravenously. | Procedure or surgery | Cyclophosphamide + TBI + BMT |
| Total Body Irradiation (TBI)Also: radiation therapyFollowing 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant. | Radiation | Cyclophosphamide + TBI + BMT |
Primary outcome
Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Richard E. Champlin, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Allogeneic Bone Marrow Transplantation and Autologous Bone Marrow Transplantation in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
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: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 25 Oct 2018.