Leukemia, Myelocytic, AcutePhase 3NCT00962767
Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission
A Phase 3 study testing gemtuzumab ozogamicin and ATRA plus 6-MP and MTX in people with Leukemia, Myelocytic, Acute, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission. Read more about this study
- Who is it for?
- Ages 18 to 61 years
- Conditions the study is for
- Leukemia, Myelocytic, Acute
- What is being tested?
- gemtuzumab ozogamicin and ATRA plus 6-MP and MTX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Dec 2007
- 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 18 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high risk disease.
- Male and female patients age > 18 years and < 61 years.
Who cannot join
- Low risk patients (WBC < 10 x 109/L and platelets > 40 x 109/L).
- Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.
- Pretreated APL.
About this study
Official title: A Randomized Study of Two Doses Gemtuzumab Ozogamicin vs. A Two-year Maintenance With Atra Plus Chemotherapy as Post-consolidation Treatment for Intermediate and High-risk Adult Patients With Acute Promyelocytic Leukemia (Apl)
The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.
- Conditions
- Leukemia, Myelocytic, Acute
- Being tested
- gemtuzumab ozogamicin, ATRA plus 6-MP and MTX
- Keywords
- Oncology comparison study
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemtuzumab ozogamicinDrug
Also called Arm A
2 IV infusions 6 mg/m2 administered monthly
ATRA plus 6-MP and MTXDrug
Also called Arm B
6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO
| Study group | Role | What they receive |
|---|---|---|
| a | Experimental | 2 doses of gemtuzumab ozogamicn administered at monthly intervals Receives: Drug: gemtuzumab ozogamicin |
| b | Active comparator | 2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX) Receives: Drug: ATRA plus 6-MP and MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission.
Measured: 5 years
Secondary outcomes (1)
Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival.
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 posted20 Aug 2009 (estimated)
- Study startMay 2002
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelocytic, AcuteStudies 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962767
- Sponsor's protocol ID
- 0903X-101128
- Status last verified
- Aug 2009
- First submitted
- 18 Aug 2009
- Last updated
- 20 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Two Doses Gemtuzumab Ozogamicin vs. A Two-year Maintenance With Atra Plus Chemotherapy as Post-consolidation Treatment for Intermediate and High-risk Adult Patients With Acute Promyelocytic Leukemia (Apl)
- ClinicalTrials.gov ID
- NCT00962767
- Acronym / sponsor ID
- 0903X-101128
- Conditions
- Leukemia, Myelocytic, Acute
- Keywords
- Oncology comparison study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Aug 2009 (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.
The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a | Experimental | Drug: gemtuzumab ozogamicin2 doses of gemtuzumab ozogamicn administered at monthly intervals |
| b | Active comparator | Drug: ATRA plus 6-MP and MTX2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX) |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high risk disease.
- Male and female patients age > 18 years and < 61 years.
Key exclusion criteria (3 listed)
- Low risk patients (WBC < 10 x 109/L and platelets > 40 x 109/L).
- Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.
- Pretreated APL.
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 |
|---|---|---|
| gemtuzumab ozogamicinAlso: Arm A2 IV infusions 6 mg/m2 administered monthly | Drug | a |
| ATRA plus 6-MP and MTXAlso: Arm B6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO | Drug | b |
Primary outcome
The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission.
Time frame: 5 years
1 secondary outcome
Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival.
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 20 Aug 2009.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gemtuzumab ozogamicin and ATRA plus 6-MP and MTX in people with Leukemia, Myelocytic, Acute, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 2 inclusion and 3 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 20 Aug 2009. 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 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.
What does the primary outcome measure?
The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission. (time frame: 5 years). 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 20 Aug 2009.