LymphomaPhase 2NCT00004231
Combination Chemotherapy, Bone Marrow or Peripheral Stem Cell Transplantation, and/or Biological Therapy in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
A Phase 2 study testing aldesleukin, filgrastim and recombinant interferon alfa in people with Lymphoma, run by Northwestern University 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 peripheral stem cell or 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 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- aldesleukin, filgrastim and recombinant interferon alfa
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Aug 2006
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed stage III, IV, or recurrent mantle cell lymphoma
- CD5 positive OR
- Evidence of bcl-1 oncogene overexpression
- Measurable or evaluable disease with at least one of the following:
- Clear cut radiographic findings
- Clearly defined bidimensional defect or mass at least 2 cm in diameter on radionuclide or CT scan
- Enlarged spleen extending at least 2 cm below costal margin with lymphomatous involvement only
- Enlarged liver with proof of lymphoma by biopsy
- CNS involvement allowed
- Fully HLA matched donor for allogeneic transplantation
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-3
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 3.0 mg/dL
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No significant cardiac disease
Other:
- No other prior malignancies except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other medical problems that would preclude study
- HIV negative
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
- Prior chemotherapy, including doxorubicin, allowed
Endocrine therapy:
- See Disease Characteristics
- Prior steroids allowed
Radiotherapy:
- See Disease Characteristics
- Prior radiotherapy allowed excluding the indicator lesions
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611
About this study
Official title: Phase II Study of Multimodality Therapy in Mantle Cell Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation and/or biological therapy in treating patients who have stage III, stage IV, or recurrent mantle cell lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the toxicities of combination chemotherapy followed by allogeneic or autologous bone marrow transplantation or peripheral blood stem cell transplantation and/or interferon and interleukin therapy in patients with refractory or stage III or IV mantle cell lymphoma.
- Determine the complete response rate in these patients after these treatments.
- Evaluate the prognostic factors in this patient population.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy consisting of cyclophosphamide IV, doxorubicin IV, and teniposide IV over 2 hours on day 1, oral prednisone on days 1-5, vincristine IV and methotrexate IV over 2 hours on day 21, cytarabine IV over 2 hours every 12 hours for a total of 2 doses on day 22, and oral leucovorin calcium every 6 hours beginning on day 22 and continuing until methotrexate levels recover. Treatment repeats every 42 days for 2 courses. Patients achieving complete response or partial response receive an additional course of induction therapy. Patients achieving maximal response following 2 courses of induction chemotherapy undergo transplantation.
Patients under 50 years with an HLA matched donor undergo allogeneic bone marrow transplantation (BMT). Patients receive busulfan IV every 6 hours for a total of 14 doses beginning on day -8 and continuing for 3.5 days. At 24 hours following the last dose of busulfan, patients receive cyclophosphamide IV over 2 hours daily for 2 days. Patients receive allogeneic bone marrow infusion on day 0.
Patients under 50 years with no HLA matched donor or patients 50-65 years old undergo autologous bone marrow or peripheral blood stem cell (PBSC) transplantation. Patients undergo PBSC mobilization following completion of cyclophosphamide, doxorubicin, and teniposide portion of induction therapy of course 3. Patients receive cytokines subcutaneously (SQ) beginning 2 days following chemotherapy and continuing through PBSC collection. If insufficient stem cells are collected and there is negative bone marrow involvement, patients undergo bone marrow harvest. Patients receive a conditioning regimen consisting of busulfan and cyclophosphamide as for allogeneic BMT. Patients receive autologous bone marrow or PBSC infusion on day 0 and filgrastim (G-CSF) SQ beginning on day 0 and continuing until blood counts recover. Following blood count recovery, patients receive maintenance therapy consisting of interferon alfa SQ and interleukin-2 SQ daily over 5 consecutive days for 4 weeks. Treatment repeats every 8 weeks for 2 courses.
Patients 65 years or older achieving complete or partial response to induction chemotherapy receive maintenance therapy as for autologous BMT. Patients achieving partial response may receive an additional 4th course of induction therapy prior to maintenance therapy.
Patients are followed at 30 days post transplant, every 3 months for 1 year, and then at least every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 15-48 patients will be accrued for this study over 3 years.
- Conditions
- Lymphoma
- Being tested
- aldesleukin, filgrastim, recombinant interferon alfa, busulfan, cyclophosphamide
- Keywords
- stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
filgrastimBiological
recombinant interferon alfaBiological
busulfanDrug
cyclophosphamideDrug
cytarabineDrug
methotrexateDrug
prednisoneDrug
teniposideDrug
allogeneic bone marrow transplantationProcedure or surgery
autologous bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
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 1999
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Northwestern 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
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Leo I. Gordon, MD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004231
- Sponsor's protocol ID
- NU 96H3
- Other IDs
- NU-96H3, NCI-G99-1659
- Status last verified
- May 2012
- First submitted
- 28 Jan 2000
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Evens AM, Winter JN, Hou N, Nelson BP, Rademaker A, Patton D, Singhal S, Frankfurt O, Tallman MS, Rosen ST, Mehta J, Gordon LI. A phase II clinical trial of intensive chemotherapy followed by consolidative stem cell transplant: long-term follow-up in newly diagnosed mantle cell lymphoma. Br J Haematol. 2008 Feb;140(4):385-93. doi: 10.1111/j.1365-2141.2007.06908.x. Epub 2007 Dec 19.
PubMed 18162124
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Multimodality Therapy in Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00004231
- Acronym / sponsor ID
- NU 96H3
- Conditions
- Lymphoma
- Keywords
- stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1999
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (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 cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation and/or biological therapy in treating patients who have stage III, stage IV, or recurrent mantle cell lymphoma.
Detailed description
OBJECTIVES:
- Determine the toxicities of combination chemotherapy followed by allogeneic or autologous bone marrow transplantation or peripheral blood stem cell transplantation and/or interferon and interleukin therapy in patients with refractory or stage III or IV mantle cell lymphoma.
- Determine the complete response rate in these patients after these treatments.
- Evaluate the prognostic factors in this patient population.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy consisting of cyclophosphamide IV, doxorubicin IV, and teniposide IV over 2 hours on day 1, oral prednisone on days 1-5, vincristine IV and methotrexate IV over 2 hours on day 21, cytarabine IV over 2 hours every 12 hours for a total of 2 doses on day 22, and oral leucovorin calcium every 6 hours beginning on day 22 and continuing until methotrexate levels recover. Treatment repeats every 42 days for 2 courses. Patients achieving complete response or partial response receive an additional course of induction therapy. Patients achieving maximal response following 2 courses of induction chemotherapy undergo transplantation.
Patients under 50 years with an HLA matched donor undergo allogeneic bone marrow transplantation (BMT). Patients receive busulfan IV every 6 hours for a total of 14 doses beginning on day -8 and continuing for 3.5 days. At 24 hours following the last dose of busulfan, patients receive cyclophosphamide IV over 2 hours daily for 2 days. Patients receive allogeneic bone marrow infusion on day 0.
Patients under 50 years with no HLA matched donor or patients 50-65 years old undergo autologous bone marrow or peripheral blood stem cell (PBSC) transplantation. Patients undergo PBSC mobilization following completion of cyclophosphamide, doxorubicin, and teniposide portion of induction therapy of course 3. Patients receive cytokines subcutaneously (SQ) beginning 2 days following chemotherapy and continuing through PBSC collection. If insufficient stem cells are collected and there is negative bone marrow involvement, patients undergo bone marrow harvest. Patients receive a conditioning regimen consisting of busulfan and cyclophosphamide as for allogeneic BMT. Patients receive autologous bone marrow or PBSC infusion on day 0 and filgrastim (G-CSF) SQ beginning on day 0 and continuing until blood counts recover. Following blood count recovery, patients receive maintenance therapy consisting of interferon alfa SQ and interleukin-2 SQ daily over 5 consecutive days for 4 weeks. Treatment repeats every 8 weeks for 2 courses.
Patients 65 years or older achieving complete or partial response to induction chemotherapy receive maintenance therapy as for autologous BMT. Patients achieving partial response may receive an additional 4th course of induction therapy prior to maintenance therapy.
Patients are followed at 30 days post transplant, every 3 months for 1 year, and then at least every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 15-48 patients will be accrued for this study over 3 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| aldesleukin | Biological | – |
| filgrastim | Biological | – |
| recombinant interferon alfa | Biological | – |
| busulfan | Drug | – |
| cyclophosphamide | Drug | – |
| cytarabine | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| leucovorin calcium | Drug | – |
| methotrexate | Drug | – |
| prednisone | Drug | – |
| teniposide | Drug | – |
| vincristine sulfate | Drug | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 6 Jun 2012.
- Results publication: PubMed 18162124Evens AM, Winter JN, Hou N, Nelson BP, Rademaker A, Patton D, Singhal S, Frankfurt O, Tallman MS, Rosen ST, Mehta J, Gordon LI. A phase II clinical trial of intensive chemotherapy followed by consolidative stem cell transplant: long-term follow-up in newly diagnosed mantle cell lymphoma. Br J Haematol. 2008 Feb;140(4):385-93. doi: 10.1111/j.1365-2141.2007.06908.x. Epub 2007 Dec 19.
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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.
Leo I. Gordon, MD study chair
Robert H. Lurie 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 aldesleukin, filgrastim and recombinant interferon alfa in people with Lymphoma, run by Northwestern University 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 6 Jun 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004231, which also lists 1 linked publication.
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 6 Jun 2012; AzTrials last refreshed its copy on 1 Nov 2026.