LeukemiaPhase 3NCT00002868
Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
A Phase 3 study testing filgrastim, recombinant interferon alfa and busulfan in people with Leukemia, run by Eastern Cooperative Oncology Group at 3 sites in 2 countries.
Trial summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Leukemia
- What is being tested?
- filgrastim, recombinant interferon alfa and busulfan
- Type of treatment
- Surgery or procedure
- How many people
- 744 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 20 Nov 1997to Mar 2004
- Phase
- Phase 3
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Newly diagnosed chronic myelogenous leukemia in chronic phase Philadelphia chromosome and/or BCR/ABL positive Initial diagnosis within 6 months of randomization No clinical or laboratory evidence of acceleration or blastic disease No contraindication to peripheral blood cell stem cell collection prior to treatment
PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No major organ impairment Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon alfa Chemotherapy: Prior hydroxyurea allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
About this study
Official title: PROSPECTIVE RANDOMISED STUDY TO COMPARE INTERFERON-ALPHA-n1 (WELLFERON) VS 'IDAC' CHEMOTHERAPY AND AUTOGRAFTING FOLLOWED BY INTERFERON ALPHA-n1 (WELLFERON) IN PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa with high-dose chemotherapy and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without peripheral stem cell transplantation in treating patients who have newly diagnosed chronic myelogenous leukemia in chronic phase.
Read the detailed description
OBJECTIVES: I. Compare overall survival in patients with chronic myelogenous leukemia in chronic phase treated with interferon alfa with or without cytarabine vs autologous peripheral blood stem cell transplantation followed by interferon alfa with or without cytarabine. II. Compare the time to blast transformation with these treatment regimens in these patients. III. Compare the number of these patients reverting to Philadelphia chromosome (Ph) negative hematopoiesis with these treatment regimens. IV. Compare the complete and major cytogenetic response rates in these patients at one year after receiving these treatment regimens and annually thereafter. V. Compare the hematological remission rate in these patients after receiving these treatment regimens. VI. Compare the duration of hematological remission and its impact on survival and blastic transformation in these patients after receiving these treatment regimens. VII. Compare the duration of Ph negative hemapoiesis and its impact on survival and blastic transformation in these patients after receiving these treatment regimens. VIII. Determine the number of these patients who fail one treatment regimen and can be rescued with the alternative. IX. Compare quality of life in these patients with these treatment regimens. X. Determine the number of these patients who tolerate these two regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients undergo mobilization chemotherapy with a regimen of the center's choice, such as either of the following: Patients receive idarubicin IV over 10 minutes, etoposide IV over 2 hours, and cytarabine IV over 2 hours on days 1-3; and filgrastim (G-CSF) subcutaneously (SC) starting day 11 and continuing until blood counts recover. OR Patients receive hydroxyurea IV daily until the neutrophil count drops below 1,000/mm3 or the platelet count drops below 20,000/mm3 followed by G-CSF SC for 3 consecutive days or until leukapheresis is complete. Following mobilization therapy, patients undergo leukapheresis within 6 months of diagnosis. Patients then undergo cytoreductive therapy consisting of oral busulfan on days -5 to -2. Autologous peripheral blood stem cells are infused on day 0. Once blood counts have recovered, patients receive interferon alfa SC 3 times a week for 8 weeks, and then daily for at least a total of 6 months or until disease progression. At the discretion of the treating physician, patients may also receive cytarabine SC once a day for 10 days each month, beginning 2 weeks after the interferon alfa therapy begins and continuing until complete cytogenetic response is achieved. Arm II: Patients receive interferon alfa SC 3 times a week for 4 weeks, and then daily for 6 months. If hematological remission is achieved after 6 months, interferon treatment is continued for at least another 6 months or until disease progression. At the discretion of the treating physician, patients may also receive cytarabine as in arm I. Quality of life is assessed at defined intervals. Patients are followed for at least 2 years.
PROJECTED ACCRUAL: Approximately 744 patients will be accrued for this study within 5 years.
- Conditions
- Leukemia
- Being tested
- filgrastim, recombinant interferon alfa, busulfan, cytarabine, etoposide
- Keywords
- chronic phase chronic myelogenous leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
recombinant interferon alfaBiological
busulfanDrug
cytarabineDrug
etoposideDrug
hydroxyureaDrug
idarubicinDrug
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 posted16 Feb 2004 (estimated)
- Study start20 Nov 1997
- Primary completionMar 2004
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 744 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ian M. Franklin, MB, PhD, Study chair, Royal Infirmary - CastleHillard M. Lazarus, MD, Study chair, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002868
- Sponsor's protocol ID
- CDR0000065146
- Other IDs
- MRC-LEUK-CML-2000, ECOG-E7995, MRC-LEUK-CML-IV, MRC-LEUK-CML-IVa, EU-96029
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 22 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE RANDOMISED STUDY TO COMPARE INTERFERON-ALPHA-n1 (WELLFERON) VS 'IDAC' CHEMOTHERAPY AND AUTOGRAFTING FOLLOWED BY INTERFERON ALPHA-n1 (WELLFERON) IN PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA
- ClinicalTrials.gov ID
- NCT00002868
- Acronym / sponsor ID
- CDR0000065146
- Conditions
- Leukemia
- Keywords
- chronic phase chronic myelogenous leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Nov 1997 (actual)
- Primary completion
- Mar 2004 (actual)
- First posted
- 16 Feb 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: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa with high-dose chemotherapy and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without peripheral stem cell transplantation in treating patients who have newly diagnosed chronic myelogenous leukemia in chronic phase.
Detailed description
OBJECTIVES: I. Compare overall survival in patients with chronic myelogenous leukemia in chronic phase treated with interferon alfa with or without cytarabine vs autologous peripheral blood stem cell transplantation followed by interferon alfa with or without cytarabine. II. Compare the time to blast transformation with these treatment regimens in these patients. III. Compare the number of these patients reverting to Philadelphia chromosome (Ph) negative hematopoiesis with these treatment regimens. IV. Compare the complete and major cytogenetic response rates in these patients at one year after receiving these treatment regimens and annually thereafter. V. Compare the hematological remission rate in these patients after receiving these treatment regimens. VI. Compare the duration of hematological remission and its impact on survival and blastic transformation in these patients after receiving these treatment regimens. VII. Compare the duration of Ph negative hemapoiesis and its impact on survival and blastic transformation in these patients after receiving these treatment regimens. VIII. Determine the number of these patients who fail one treatment regimen and can be rescued with the alternative. IX. Compare quality of life in these patients with these treatment regimens. X. Determine the number of these patients who tolerate these two regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients undergo mobilization chemotherapy with a regimen of the center's choice, such as either of the following: Patients receive idarubicin IV over 10 minutes, etoposide IV over 2 hours, and cytarabine IV over 2 hours on days 1-3; and filgrastim (G-CSF) subcutaneously (SC) starting day 11 and continuing until blood counts recover. OR Patients receive hydroxyurea IV daily until the neutrophil count drops below 1,000/mm3 or the platelet count drops below 20,000/mm3 followed by G-CSF SC for 3 consecutive days or until leukapheresis is complete. Following mobilization therapy, patients undergo leukapheresis within 6 months of diagnosis. Patients then undergo cytoreductive therapy consisting of oral busulfan on days -5 to -2. Autologous peripheral blood stem cells are infused on day 0. Once blood counts have recovered, patients receive interferon alfa SC 3 times a week for 8 weeks, and then daily for at least a total of 6 months or until disease progression. At the discretion of the treating physician, patients may also receive cytarabine SC once a day for 10 days each month, beginning 2 weeks after the interferon alfa therapy begins and continuing until complete cytogenetic response is achieved. Arm II: Patients receive interferon alfa SC 3 times a week for 4 weeks, and then daily for 6 months. If hematological remission is achieved after 6 months, interferon treatment is continued for at least another 6 months or until disease progression. At the discretion of the treating physician, patients may also receive cytarabine as in arm I. Quality of life is assessed at defined intervals. Patients are followed for at least 2 years.
PROJECTED ACCRUAL: Approximately 744 patients will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 15 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 |
|---|---|---|
| filgrastim | Biological | – |
| recombinant interferon alfa | Biological | – |
| busulfan | Drug | – |
| cytarabine | Drug | – |
| etoposide | Drug | – |
| hydroxyurea | Drug | – |
| idarubicin | Drug | – |
| 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 22 Jun 2023.
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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 M. Franklin, MB, PhD study chair
Royal Infirmary - Castle
Hillard M. Lazarus, MD study chair
Case Comprehensive Cancer Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing filgrastim, recombinant interferon alfa and busulfan in people with Leukemia, run by Eastern Cooperative Oncology Group at 3 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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 22 Jun 2023.