Mantle Cell LymphomaPhase 2NCT00586755
Intensive Induction Therapy Followed by High Dose Chemo and BM Transplant for Mantle Cell Lymphoma
A Phase 2 study testing Intensive Induction-BMT in people with Mantle Cell Lymphoma, run by Duke University.
Trial summary
Patients with mantle cell lymphoma have a grave prognosis. They usually have an initial response to therapy, however progress early in the course of the disease and have very poor survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Intensive Induction-BMT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Feb 1998to Nov 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have biopsy proven mantle cell lymphoma confirming mantle cell lymphoma. (Flow cytometry, and cyclin D1 or t (11;14) tests of disease site should be done if available at some time in the patient's course before this therapy)
- Radiologic staging studies may be performed up to 6 weeks prior to starting therapy and not be repeated if the treating physician feels it unnecessary
- No other prior malignancy is permitted except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year.
- Age > or = to 18 years of age
- For patients who are in first remission from a prior regimen, at least 3 weeks must elapse from a prior chemotherapy and at least 1 week from radiation or antibody therapy.
Who cannot join
- Significant medical and/or psychiatric illness which, in the opinion of the investigators, may compromise any aspect of the planned treatment.
- The patient cannot have been exposed to chemotherapy to treat any of these diseases (other than mantle cell lymphoma) for at least 3 years prior to entry on this protocol.
About this study
Official title: Intensive Induction Therapy Followed by Early High Dose Chemotherapy and Bone Marrow Transplantation for Mantle Cell Lymphoma
Patients with mantle cell lymphoma have a grave prognosis. They usually have an initial response to therapy, however progress early in the course of the disease and have very poor survival. We hypothesize that the emergence of drug resistance is responsible for this early failure of therapy and therefore intensive therapy at induction followed by high dose therapy immediately may produce a better outcome.
Read the detailed description
Subjects will undergo an induction regimen consisting of 1 cycle of cytarabine (3 gm/m2 Intravenously over 1 hour every 12 hours for 8 total doses) and mitoxantrone (10 mg/m2/d intravenously [IV] over 30 minutes daily on days 1, 2, and 3). This will be combined with Alemtuzumab (anti-CD52 antibody) for 6-8 weeks. If, after this one cycle, subjects have not had progression of disease as noted on physical exam or radiographic scans, they will proceed to stem cell mobilization with cyclophosphamide. This will be immediately followed by high dose therapy with stem cell support. Following count recovery, rituximab will be used for 8 total doses as consolidation therapy. Involved field irradiation may be given post-transplant to those with localized bulky disease as well. Day -6: Carmustine (BCNU): 15 mg/kg (or 550 mg/m2) IV over 2 hrs. Day -4: Etoposide Day -2: Cyclophosphamide 100 mg/kg in 1 liter D5W over 2 hours.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Intensive Induction-BMT
- Keywords
- Intensive Induction, High Dose Chemotherapy, Bone Marrow Transplantation, Mantle Cell Lymphoma
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Induction-BMTProcedure or surgery
Patients will undergo an induction regimen consisting of 1 cycle of cytarabine (3 gm/m2 intravenously over 1 hour every 12 hours for 8 total doses) and mitoxantrone (10 mg/m2/d intravenously over 30 minutes daily on days 1, 2, and 3). This will be combined with Alemtuzumab (anti-CD52 antibody) for 6-8 weeks. If, after this one cycle, subjects have not had progression of disease as noted on physical exam or radiographic scans, they will proceed to stem cell mobilization with cyclophosphamide. This will be immediately followed by high dose therapy with stem cell support. Following count recovery, rituximab will be used for 8 total doses as consolidation therapy. Involved field irradiation may be given post-transplant to those with localized bulky disease as well.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Induction-BMT | Experimental | Patients will undergo induction regimen and stem cell mobilization with cyclophosphamide for bone marrow transplant (BMT). This will be immediately followed by high dose therapy with stem cell support. Receives: Procedure: Intensive Induction-BMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
Number of patients who did not have documented recurrence for at 1 year after bone marrow transplantation.
We would like to detect an improvement over 0.25 in DFS at one year. Thirty (30) patients will be accrued and complete the transplant phase of therapy. We anticipate only 50% of patients enrolling to complete transplant, noting that approximately 60 patients total will need to be accrued. With 30 patients we can detect an improvement as small as 17% in magnitude, i.e., from an assumed 1-year DFS of 25% to a 1-year DFS of 42% with approximately 80% power. This is based on a one-sided test of hypothesis, testing at significance level 0.05 and the assumption that the true underlying 1-year DFS is 0.25. Greater differences in DFS are expected. If the 1-year DFS with the new treatment is greater than 42% the power is increased.
Measured: 1 year
Progression Free Survival (PFS)
The number of patients who did not have disease progression, recurrence or die for 1 year after bone marrow transplantation.
Measured: 1 year
Secondary outcomes (4)
Response to the induction regimen
Number of patients who respond to transplant. Complete Response (CR): No measurable disease. Remission must last for more than 4 weeks.
Complete Response with Residual Abnormality: CR with persistent mass in the mediastinum or abdomen that has regressed >50% following therapy and then stabilized with NO change over the rest of therapy.
Partial Response (PR): Reduction of >50% in the sum of the products of the perpendicular diameters of all measurable lesions lasting more than 4 weeks. Disappearance of constitutional symptoms must occur. >30% reduction in extension of the liver below the costal margin at the midclavicular line and the xiphoid process and normalization of liver function tests.
Stable Disease (SD): < 50% decrease or < 25% increase in the sum of the perpendicular diameters of measurable lesions and no new lesions.
Progressive Disease (PD): >= 25% increase in the product of the perpendicular diameters of any lesion or new areas of malignant disease.
Measured: 12 weeks
Response to the transplant phase of therapy
Number of patients who respond to transplant. Complete Response (CR): No measurable disease. Remission must last for more than 4 weeks.
Complete Response with Residual Abnormality: CR with persistent mass in the mediastinum or abdomen that has regressed >50% following therapy and then stabilized with NO change over the rest of therapy.
Partial Response (PR): Reduction of >50% in the sum of the products of the perpendicular diameters of all measurable lesions lasting more than 4 weeks. Disappearance of constitutional symptoms must occur. >30% reduction in extension of the liver below the costal margin at the midclavicular line and the xiphoid process and normalization of liver function tests.
Stable Disease (SD): < 50% decrease or < 25% increase in the sum of the perpendicular diameters of measurable lesions and no new lesions.
Progressive Disease (PD): >= 25% increase in the product of the perpendicular diameters of any lesion or new areas of malignant disease.
Measured: 2 years
Toxicity of the trial
Number of grade 3 or higher events related to study treatment. Toxicities were assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 2.0.
Measured: 2 years
Overall Survival (OS)
Number of years patients survived after bone marrow transplantation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startFeb 1998
- Primary completionOct 2007
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rizzieri, MD, Principal investigator, Duke University Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586755
- Sponsor's protocol ID
- 2165
- Status last verified
- Jul 2014
- First submitted
- 21 Dec 2007
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Induction Therapy Followed by Early High Dose Chemotherapy and Bone Marrow Transplantation for Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00586755
- Acronym / sponsor ID
- 2165
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Intensive Induction, High Dose Chemotherapy, Bone Marrow Transplantation, Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 1998
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Jan 2008 (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.
Patients with mantle cell lymphoma have a grave prognosis. They usually have an initial response to therapy, however progress early in the course of the disease and have very poor survival. We hypothesize that the emergence of drug resistance is responsible for this early failure of therapy and therefore intensive therapy at induction followed by high dose therapy immediately may produce a better outcome.
Detailed description
Subjects will undergo an induction regimen consisting of 1 cycle of cytarabine (3 gm/m2 Intravenously over 1 hour every 12 hours for 8 total doses) and mitoxantrone (10 mg/m2/d intravenously [IV] over 30 minutes daily on days 1, 2, and 3). This will be combined with Alemtuzumab (anti-CD52 antibody) for 6-8 weeks. If, after this one cycle, subjects have not had progression of disease as noted on physical exam or radiographic scans, they will proceed to stem cell mobilization with cyclophosphamide. This will be immediately followed by high dose therapy with stem cell support. Following count recovery, rituximab will be used for 8 total doses as consolidation therapy. Involved field irradiation may be given post-transplant to those with localized bulky disease as well. Day -6: Carmustine (BCNU): 15 mg/kg (or 550 mg/m2) IV over 2 hrs. Day -4: Etoposide Day -2: Cyclophosphamide 100 mg/kg in 1 liter D5W over 2 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Induction-BMT | Experimental | Procedure: Intensive Induction-BMTPatients will undergo induction regimen and stem cell mobilization with cyclophosphamide for bone marrow transplant (BMT). This will be immediately followed by high dose therapy with stem cell support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have biopsy proven mantle cell lymphoma confirming mantle cell lymphoma. (Flow cytometry, and cyclin D1 or t (11;14) tests of disease site should be done if available at some time in the patient's course before this therapy)
- Radiologic staging studies may be performed up to 6 weeks prior to starting therapy and not be repeated if the treating physician feels it unnecessary
- No other prior malignancy is permitted except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year.
- Age > or = to 18 years of age
- For patients who are in first remission from a prior regimen, at least 3 weeks must elapse from a prior chemotherapy and at least 1 week from radiation or antibody therapy.
Key exclusion criteria (2 listed)
- Significant medical and/or psychiatric illness which, in the opinion of the investigators, may compromise any aspect of the planned treatment.
- The patient cannot have been exposed to chemotherapy to treat any of these diseases (other than mantle cell lymphoma) for at least 3 years prior to entry on this protocol.
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 |
|---|---|---|
| Intensive Induction-BMTPatients will undergo an induction regimen consisting of 1 cycle of cytarabine (3 gm/m2 intravenously over 1 hour every 12 hours for 8 total doses) and mitoxantrone (10 mg/m2/d intravenously over 30 minutes daily on days 1, 2, and 3). This will be combined with Alemtuzumab (anti-CD52 antibody) for 6-8 weeks. If, after this one cycle, subjects have not had progression of disease as noted on physical exam or radiographic scans, they will proceed to stem cell mobilization with cyclophosphamide. This will be immediately followed by high dose therapy with stem cell support. Following count recovery, rituximab will be used for 8 total doses as consolidation therapy. Involved field irradiation may be given post-transplant to those with localized bulky disease as well. | Procedure or surgery | Intensive Induction-BMT |
Primary outcome
Disease Free Survival (DFS)
Time frame: 1 year
Number of patients who did not have documented recurrence for at 1 year after bone marrow transplantation. We would like to detect an improvement over 0.25 in DFS at one year. Thirty (30) patients will be accrued and complete the transplant phase of therapy. We anticipate only 50% of patients enrolling to complete transplant, noting that approximately 60 patients total will need to be accrued. With 30 patients we can detect an improvement as small as 17% in magnitude, i.e., from an assumed 1-year DFS of 25% to a 1-year DFS of 42% with approximately 80% power. This is based on a one-sided test of hypothesis, testing at significance level 0.05 and the assumption that the true underlying 1-year DFS is 0.25. Greater differences in DFS are expected. If the 1-year DFS with the new treatment is greater than 42% the power is increased.
Progression Free Survival (PFS)
Time frame: 1 year
The number of patients who did not have disease progression, recurrence or die for 1 year after bone marrow transplantation.
4 secondary outcomes
Response to the induction regimen
Time frame: 12 weeks
Response to the transplant phase of therapy
Time frame: 2 years
Toxicity of the trial
Time frame: 2 years
Overall Survival (OS)
Time frame: 5 years
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 18 Jul 2014.
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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.
David Rizzieri, MD principal investigator
Duke University Health Systems
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensive Induction-BMT in people with Mantle Cell Lymphoma, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Disease Free Survival (DFS) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 18 Jul 2014.