LeukemiaPhase 2NCT00528398
Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
A Phase 2 study testing cytarabine and idarubicin in people with Leukemia, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Leukemia
- What is being tested?
- cytarabine and idarubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1994to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed acute myeloid leukemia (AML)
- Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
- FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease
- Previously untreated with radiotherapy or chemotherapy
- Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
- Patients with prior myelodysplastic syndrome are eligible
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- Extramedullary leukemia allowed
- AML with lymphoid markers allowed
- See Disease Characteristics
- Prior hydroxyurea or corticosteroids allowed
- At least 48 hours since prior and no concurrent itraconazole or fluconazole
Who cannot join
- Blastic transformation of chronic myelogenous leukemia
- Biphenotypic leukemia
- FAB M3 disease (acute promyelocytic leukemia)
- PATIENT CHARACTERISTICS:
- Life expectancy ≥ 6 weeks
- Total bilirubin < 1.5 g/dL
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- AST and ALT < 5 times upper limit of normal (ULN)
- Creatinine < 1.5 mg/dL OR creatinine clearance > 70 mL/min
- Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
- HIV antibody-negative
- PRIOR CONCURRENT THERAPY:
- More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
About this study
Official title: Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- Determine the complete remission rate (CR).
- Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy.
- Further evaluate the toxicity of this regimen.
OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
- Conditions
- Leukemia
- Being tested
- cytarabine, idarubicin
- Keywords
- adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), secondary acute myeloid leukemia, untreated adult acute myeloid leukemia
- Medical subject headings
- Leukemia, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Erythroblastic, Acute, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytarabineDrug
Also called Cytosine Arabinoside, Cytosar-U, Depocyt
idarubicinDrug
Also called 4-demethoxydaunorubicin, Idamycin, Zavedos
| Study group | Role | What they receive |
|---|---|---|
| Treatment (idarubicin, cytarabine) | Experimental | Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin. Receives: Drug: cytarabine; Drug: idarubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission (CR)
The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.
Measured: 7 days post completion of induction chemotherapy
Secondary outcomes (1)
Bone Marrow at Day 7 Post-Induction Chemotherapy
Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)
Measured: 7 days post completion of induction chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startSep 1994
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anthony S. Stein, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528398
- Sponsor's protocol ID
- 93139
- Other IDs
- P30CA033572, CHNMC-93139, CHNMC-93139-94-03-1, CDR0000564537
- Status last verified
- Dec 2016
- First submitted
- 10 Sep 2007
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)
- ClinicalTrials.gov ID
- NCT00528398
- Acronym / sponsor ID
- 93139
- Conditions
- Leukemia
- Keywords
- adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult erythroleukemia (M6a)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1994
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Sep 2007 (estimated)
- Results
- Posted 6 Feb 2017
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, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- Determine the complete remission rate (CR).
- Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy.
- Further evaluate the toxicity of this regimen.
OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (idarubicin, cytarabine) | Experimental | Drug: cytarabine, Drug: idarubicinPatients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Newly diagnosed acute myeloid leukemia (AML)
- Previously untreated with radiotherapy or chemotherapy
- Patients with prior myelodysplastic syndrome are eligible
- Extramedullary leukemia allowed
- AML with lymphoid markers allowed
Key exclusion criteria (12 listed)
- Blastic transformation of chronic myelogenous leukemia
- Biphenotypic leukemia
- FAB M3 disease (acute promyelocytic leukemia)
- Life expectancy ≥ 6 weeks
- Total bilirubin < 1.5 g/dL
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 |
|---|---|---|
| cytarabineAlso: Cytosine Arabinoside, Cytosar-U, Depocyt | Drug | Treatment (idarubicin, cytarabine) |
| idarubicinAlso: 4-demethoxydaunorubicin, Idamycin, Zavedos | Drug | Treatment (idarubicin, cytarabine) |
Primary outcome
Complete Remission (CR)
Time frame: 7 days post completion of induction chemotherapy
The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.
1 secondary outcome
Bone Marrow at Day 7 Post-Induction Chemotherapy
Time frame: 7 days post completion of induction chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anthony S. Stein, MD principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cytarabine and idarubicin in people with Leukemia, run by City of Hope Medical Center at 2 sites 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?
The sponsor lists 11 inclusion and 12 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Remission (CR) (time frame: 7 days post completion of induction chemotherapy). 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 6 Feb 2017.