LeukemiaPhase 2NCT00018954
Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia and Diffuse Non-Hodgkin's Lymphoma
A Phase 2 study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia and Lymphoma, run by National Institutes of Health Clinical Center (CC) at 5 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of two treatment regimens for patients in developing countries with diffuse non-Hodgkin's… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- asparaginase, cyclophosphamide and cytarabine
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 5 sitesin 3 countries
- Study dates
- Oct 1992to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Newly diagnosed acute lymphoblastic leukemia (ALL)
- Lymphoblasts comprising more than 25% of nucleated cells on bone marrow aspirate
- Associated with an appropriate clinical syndrome
- OR
- Histologically proven newly diagnosed diffuse non-Hodgkin's lymphoma (NHL)
- Immunologic and/or cytochemical confirmation of diagnosis preferred
PATIENT CHARACTERISTICS:
Age:
- ALL:
- Under 25
- NHL:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior therapy for ALL or NHL
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
India3 sites
Kidwai Memorial Institute of Oncology
Bangalore, 560029
Cancer Institute (W.I.A.)
Madras, 600020
Tata Memorial Centre
Mumbai, 400012
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: PILOT MULTINATIONAL PROTOCOLS IN ACUTE LYMPHOBLASTIC LEUKEMIA AND DIFFUSE NON-HODGKIN'S LYMPHOMA
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of two treatment regimens for patients in developing countries with diffuse non-Hodgkin's lymphoma and acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
- Provide a standard protocol for specific therapy that is relatively easy to administer and relatively inexpensive but conforms to modern treatment principles, and determine whether such therapy can be administered safely and effectively in patients with acute lymphoblastic lymphoma or diffuse non-Hodgkin's lymphoma who live in developing countries.
- Determine the rates of relapse and survival in patients treated with these protocols, and relate this data to disease subtype and clinical presentation in order to obtain a database on which to build future stratagems.
OUTLINE: This is a multicenter study.
Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma with any degree of bone marrow involvement are assigned to Protocol MCP-841. Patients with mediastinal or localized lymphoblastic lymphoma (a single nodal or extranodal site) without bone marrow involvement, or other types of diffuse non-Hodgkin's lymphoma with or without bone marrow involvement are assigned to Protocol MCP-842.
Protocol MCP-841:
- First induction therapy: Patients receive daunorubicin (DNR) IV on days 8, 15, and 29; vincristine (VCR) IV on days 1, 8, 15, 22, and 29; asparaginase (ASP) intramuscularly (IM) every other day on days 2-20; oral prednisone (PRED) on days 1-28; and methotrexate (MTX) intrathecally (IT) on days 1, 8, 15, and 22. Second induction therapy: Patients receive oral mercaptopurine (MP) on days 1-7 and 15-21; cyclophosphamide (CTX) IV over 30 minutes on days 1 and 15; MTX IT as in first induction therapy; and cranial irradiation on days 4-14.
- Alternative to second induction (if a cranial irradiation facility is unavailable): Patients receive MP and CTX as in second induction therapy; cytarabine (ARA-C) IV every 12 hours on days 1, 2, 15, 16, 29, and 30; and MTX IT on days 8 and 22.
Patients with low-risk disease (WBC no greater than 10,000/mm3, age 3 to 6 years, no prominent lymphadenopathy (less than 3 cm in diameter in each nodal region), normal CSF, no mediastinal mass, no enlargement of liver or spleen, and no cranial nerve palsies) proceed directly to maintenance therapy. All other patients are considered high risk, and they repeat first induction therapy and then proceed to consolidation therapy.
- Consolidation therapy: Patients receive MP and CTX as in second induction therapy, VCR IV on days 1 and 15, and ARA-C subcutaneously (SC) every 12 hours on days 1-3 and 15-17.
- Maintenance therapy: Patients receive VCR IV on day 1; DNR IV on day 1; oral PRED on days 1-7; ASP IM on days 1, 3, 5, and 7; and oral MTX once weekly and oral MP daily on days 15-35, 43-63, and 71-91. Maintenance therapy continues for a total of 6 courses.
Protocol MCP-842:
- Patients undergo surgical resection of intra-abdominal masses, if feasible. Patients with low-risk disease (completely resected tumor or a single extra-abdominal site of involvement (other than the mediastinum), but without lymphoblastic lymphoma) are assigned to treatment group 2. All other patients, including those with lymphoblastic lymphoma without bone marrow involvement, are considered high risk and they are assigned to treatment group 1.
- Group 1 (high risk): Patients receive one course of regimen A comprising CTX IV over 15 minutes on days 1-4; VCR IV on days 1, 8, and 15; doxorubicin (DOX) IV on days 1 and 2; ARA-C IV over 3 hours every 12 hours on day 1; ARA-C IT on day 4; and MTX IT on days 8 and 12. Patients then receive one course of regimen B comprising ifosfamide IV over 30 minutes on days 1-5, etoposide IV over 1 hour and MTX IV on days 1-3, VCR IV on day 8, ARA-C IT on days 1 and 4, and MTX IT as in regimen A. Patients then receive a second course of regimen A, followed by a second course of regimen B.
- Group 2 (low risk): Patients receive one course of regimen A, followed by one course of regimen B, and then a second course of regimen A. DOX is withheld during both courses of regimen A. IT therapy is withheld during the second course of regimen A.
Patients are followed every 2 months for 1 year (Protocol MCP-841) or at 1, 2, 3, 4, 6, and 8 months (Protocol MCP-842), every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study.
- Being tested
- asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, doxorubicin hydrochloride
- Keywords
- stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, stage I adult diffuse small cleaved cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult Burkitt lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asparaginaseDrug
cyclophosphamideDrug
cytarabineDrug
daunorubicin hydrochlorideDrug
etoposideDrug
ifosfamideDrug
mercaptopurineDrug
methotrexateDrug
prednisoneDrug
conventional surgeryProcedure 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 posted12 Jun 2003 (estimated)
- Study startOct 1992
- Study completionOct 2002
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 LeukemiaStudies of the same condition, open and under way.
- 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
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ian Trevor Magrath, MD, FRCP, FRCPath, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018954
- Sponsor's protocol ID
- CDR0000077227
- Other IDs
- NCI-92-C-0030, NCI-T91-0259N, OH92-C-0030
- Status last verified
- Feb 2012
- First submitted
- 11 Jul 2001
- Last updated
- 20 Feb 2012
- Results posted
- No
Publications
Gad-el-Mawla N, Hussein MH, Abdel-Hadi S, el-Taneer O, Adde M, Magrath I. Childhood non-Hodgkin's lymphoma in Egypt: preliminary results of treatment with a new ifosfamide-containing regimen. Cancer Chemother Pharmacol. 1989;24 Suppl 1:S20-3. doi: 10.1007/BF00253233.
PubMed 2758567
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT MULTINATIONAL PROTOCOLS IN ACUTE LYMPHOBLASTIC LEUKEMIA AND DIFFUSE NON-HODGKIN'S LYMPHOMA
- ClinicalTrials.gov ID
- NCT00018954
- Acronym / sponsor ID
- CDR0000077227
- Keywords
- stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, stage I adult diffuse small cleaved cell lymphoma, stage I adult diffuse mixed cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1992
- Study completion
- Oct 2002 (actual)
- First posted
- 12 Jun 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of two treatment regimens for patients in developing countries with diffuse non-Hodgkin's lymphoma and acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
- Provide a standard protocol for specific therapy that is relatively easy to administer and relatively inexpensive but conforms to modern treatment principles, and determine whether such therapy can be administered safely and effectively in patients with acute lymphoblastic lymphoma or diffuse non-Hodgkin's lymphoma who live in developing countries.
- Determine the rates of relapse and survival in patients treated with these protocols, and relate this data to disease subtype and clinical presentation in order to obtain a database on which to build future stratagems.
OUTLINE: This is a multicenter study.
Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma with any degree of bone marrow involvement are assigned to Protocol MCP-841. Patients with mediastinal or localized lymphoblastic lymphoma (a single nodal or extranodal site) without bone marrow involvement, or other types of diffuse non-Hodgkin's lymphoma with or without bone marrow involvement are assigned to Protocol MCP-842.
Protocol MCP-841:
- First induction therapy: Patients receive daunorubicin (DNR) IV on days 8, 15, and 29; vincristine (VCR) IV on days 1, 8, 15, 22, and 29; asparaginase (ASP) intramuscularly (IM) every other day on days 2-20; oral prednisone (PRED) on days 1-28; and methotrexate (MTX) intrathecally (IT) on days 1, 8, 15, and 22. Second induction therapy: Patients receive oral mercaptopurine (MP) on days 1-7 and 15-21; cyclophosphamide (CTX) IV over 30 minutes on days 1 and 15; MTX IT as in first induction therapy; and cranial irradiation on days 4-14.
- Alternative to second induction (if a cranial irradiation facility is unavailable): Patients receive MP and CTX as in second induction therapy; cytarabine (ARA-C) IV every 12 hours on days 1, 2, 15, 16, 29, and 30; and MTX IT on days 8 and 22.
Patients with low-risk disease (WBC no greater than 10,000/mm3, age 3 to 6 years, no prominent lymphadenopathy (less than 3 cm in diameter in each nodal region), normal CSF, no mediastinal mass, no enlargement of liver or spleen, and no cranial nerve palsies) proceed directly to maintenance therapy. All other patients are considered high risk, and they repeat first induction therapy and then proceed to consolidation therapy.
- Consolidation therapy: Patients receive MP and CTX as in second induction therapy, VCR IV on days 1 and 15, and ARA-C subcutaneously (SC) every 12 hours on days 1-3 and 15-17.
- Maintenance therapy: Patients receive VCR IV on day 1; DNR IV on day 1; oral PRED on days 1-7; ASP IM on days 1, 3, 5, and 7; and oral MTX once weekly and oral MP daily on days 15-35, 43-63, and 71-91. Maintenance therapy continues for a total of 6 courses.
Protocol MCP-842:
- Patients undergo surgical resection of intra-abdominal masses, if feasible. Patients with low-risk disease (completely resected tumor or a single extra-abdominal site of involvement (other than the mediastinum), but without lymphoblastic lymphoma) are assigned to treatment group 2. All other patients, including those with lymphoblastic lymphoma without bone marrow involvement, are considered high risk and they are assigned to treatment group 1.
- Group 1 (high risk): Patients receive one course of regimen A comprising CTX IV over 15 minutes on days 1-4; VCR IV on days 1, 8, and 15; doxorubicin (DOX) IV on days 1 and 2; ARA-C IV over 3 hours every 12 hours on day 1; ARA-C IT on day 4; and MTX IT on days 8 and 12. Patients then receive one course of regimen B comprising ifosfamide IV over 30 minutes on days 1-5, etoposide IV over 1 hour and MTX IV on days 1-3, VCR IV on day 8, ARA-C IT on days 1 and 4, and MTX IT as in regimen A. Patients then receive a second course of regimen A, followed by a second course of regimen B.
- Group 2 (low risk): Patients receive one course of regimen A, followed by one course of regimen B, and then a second course of regimen A. DOX is withheld during both courses of regimen A. IT therapy is withheld during the second course of regimen A.
Patients are followed every 2 months for 1 year (Protocol MCP-841) or at 1, 2, 3, 4, 6, and 8 months (Protocol MCP-842), every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- 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 |
|---|---|---|
| asparaginase | Drug | – |
| cyclophosphamide | Drug | – |
| cytarabine | Drug | – |
| daunorubicin hydrochloride | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| ifosfamide | Drug | – |
| mercaptopurine | Drug | – |
| methotrexate | Drug | – |
| prednisone | Drug | – |
| vincristine sulfate | Drug | – |
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
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 20 Feb 2012.
- Results publication: PubMed 2758567Gad-el-Mawla N, Hussein MH, Abdel-Hadi S, el-Taneer O, Adde M, Magrath I. Childhood non-Hodgkin's lymphoma in Egypt: preliminary results of treatment with a new ifosfamide-containing regimen. Cancer Chemother Pharmacol. 1989;24 Suppl 1:S20-3. doi: 10.1007/BF00253233.
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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.
Ian Trevor Magrath, MD, FRCP, FRCPath study chair
National Cancer Institute (NCI)
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia and Lymphoma, run by National Institutes of Health Clinical Center (CC) at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India, United States, Egypt. 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 NCT00018954, 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 20 Feb 2012.