AnemiaPhase 2NCT00004215
Leridistim Compared With Filgrastim in Treating Older Patients With Acute Myeloid Leukemia
A Phase 2 study testing filgrastim, leridistim and cytarabine in people with Anemia and Leukemia, run by Memorial Sloan Kettering Cancer Center 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. Colony-stimulating factors such as leridistim and filgrastim increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Anemia, Leukemia, Neutropenia
- What is being tested?
- filgrastim, leridistim and cytarabine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Aug 2000
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Induction phase: Cytologically proven de novo acute myeloid leukemia (not M3) Eligible to receive cytarabine and daunorubicin Circulating blast count no greater than 75,000/mL (hydroxyurea or leukapheresis allowed to decrease blast count) No blast transformation of chronic myelogenous leukemia No myelodysplastic syndrome or antecedent hematologic disorder longer than 6 months Post Induction Phase: Severe bone marrow aplasia (less than 5% blasts and less than 10% cellularity) No persistent leukemia after 2 induction courses
PATIENT CHARACTERISTICS: Age: 55 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No significant cardiac disease No cardiac arrhythmia No uncontrolled hypertension No recent myocardial infarction or ischemia Other: No uncontrolled metabolic condition that would preclude study No psychiatric condition that would preclude study HIV negative Hepatitis B surface antigen negative No known hypersensitivity to corticosteroids, E. coli protein, interleukin-3, SC-55494, SC-68420, leridistim, milodistim, or filgrastim (G-CSF)
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interleukin-3, milodistim, SC-55494, SC-68420, or leridistim No prior peripheral blood stem cell or bone marrow transplantation No concurrent epoetin alfa or interleukin-11 Chemotherapy: See Disease Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: At least 2 weeks since prior surgery (except catheter placement or biopsy) Other: At least 3 weeks since prior investigational drug No other concurrent investigational drug
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Clinical Protocol for a Phase II Study of Leridistim (SC-70935) in Adult Patients (Age>55) With Acute Myeloid Leukemia (AML) Receiving Chemotherapy With the Cytarabine and Daunorubicin "7+3" Regimen
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as leridistim and filgrastim increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Randomized phase II trial to compare the effectiveness of leridistim with that of filgrastim to reduce side effects in older patients who are receiving cytarabine and daunorubicin for acute myeloid leukemia.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose or hematopoietically active dose of leridistim administered with induction chemotherapy in older patients with acute myeloid leukemia. II. Determine the effect of leridistim on the duration of grade IV neutropenia during the induction course in these patients. III. Determine the safety and tolerability of leridistim in these patients. IV. Compare the effect of leridistim vs filgrastim (G-CSF) on the duration of thrombocytopenia, the incidence of infection, and the need for IV antibiotics in these patients. V. Compare the effect of leridistim vs G-CSF on the number of days of platelet and/or red blood cell transfusions in these patients.
OUTLINE: This is a dose escalation study of leridistim and then a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. All patients receive induction chemotherapy consisting of daunorubicin IV over 15-30 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients who do not achieve aplasia after one induction course may receive a second course. Dose Escalation Phase: Patients receive leridistim subcutaneously (SQ) every other day beginning on day 11-14 and continuing for 42 days or until blood counts recover. Cohorts of 6 patients receive escalating doses of leridistim until the maximum tolerated dose (MTD) or hematopoietically active dose (HAD) has been determined. The MTD is defined as the dose prior to the dose level at which at least 2 of the same dose limiting toxicities occur in different patients. Consolidation Phase: Patients then receive consolidation chemotherapy consisting of cytarabine IV over 1 hour every 12 hours (patients 70 years and under) or every 24 hours (patients over 70 years) on days 1-6. Beginning 24-48 hours after completion of consolidation chemotherapy, patients receive leridistim as above. Randomized Phase: Eligible patients will receive induction and consolidation chemotherapy as outlined above. Then patients are randomized to one of two treatments. Arm I: Patients receive leridistim SQ every other day for up to 42 days or until blood counts recover. Arm II: Patients receive filgrastim (G-CSF) SQ daily for up to 42 days or until blood counts recover. Patients are followed at day 30 and then at 6 and 12 months.
PROJECTED ACCRUAL: A total of 86 patients (36 for phase I and 50 for phase II) will be accrued for this study.
- Conditions
- Anemia, Leukemia, Neutropenia, Thrombocytopenia
- Being tested
- filgrastim, leridistim, cytarabine, daunorubicin hydrochloride
- Keywords
- untreated adult acute myeloid leukemia, adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute megakaryoblastic leukemia (M7), adult acute monocytic leukemia (M5b), anemia, neutropenia, thrombocytopenia, adult acute minimally differentiated myeloid leukemia (M0)
- Medical subject headings
- Anemia, Leukemia, Neutropenia, Thrombocytopenia, Leukemia, Erythroblastic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
leridistimBiological
cytarabineDrug
daunorubicin hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2004 (estimated)
- Study startAug 1999
- Primary completionAug 2000
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Supportive care
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Mark Lawrence Heaney, MD, PhD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004215
- Sponsor's protocol ID
- 99-055
- Other IDs
- CDR0000067436, MCC-11506, SC-IN5-99-12-011, NCI-G99-1652
- Status last verified
- Jun 2013
- First submitted
- 28 Jan 2000
- Last updated
- 19 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol for a Phase II Study of Leridistim (SC-70935) in Adult Patients (Age>55) With Acute Myeloid Leukemia (AML) Receiving Chemotherapy With the Cytarabine and Daunorubicin "7+3" Regimen
- ClinicalTrials.gov ID
- NCT00004215
- Acronym / sponsor ID
- 99-055
- Conditions
- Anemia, Leukemia, Neutropenia, Thrombocytopenia
- Keywords
- untreated adult acute myeloid leukemia, adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute megakaryoblastic leukemia (M7), adult acute monocytic leukemia (M5b)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1999
- Primary completion
- Aug 2000 (actual)
- Study completion
- Aug 2000 (actual)
- First posted
- 9 Aug 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as leridistim and filgrastim increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Randomized phase II trial to compare the effectiveness of leridistim with that of filgrastim to reduce side effects in older patients who are receiving cytarabine and daunorubicin for acute myeloid leukemia.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose or hematopoietically active dose of leridistim administered with induction chemotherapy in older patients with acute myeloid leukemia. II. Determine the effect of leridistim on the duration of grade IV neutropenia during the induction course in these patients. III. Determine the safety and tolerability of leridistim in these patients. IV. Compare the effect of leridistim vs filgrastim (G-CSF) on the duration of thrombocytopenia, the incidence of infection, and the need for IV antibiotics in these patients. V. Compare the effect of leridistim vs G-CSF on the number of days of platelet and/or red blood cell transfusions in these patients.
OUTLINE: This is a dose escalation study of leridistim and then a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. All patients receive induction chemotherapy consisting of daunorubicin IV over 15-30 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients who do not achieve aplasia after one induction course may receive a second course. Dose Escalation Phase: Patients receive leridistim subcutaneously (SQ) every other day beginning on day 11-14 and continuing for 42 days or until blood counts recover. Cohorts of 6 patients receive escalating doses of leridistim until the maximum tolerated dose (MTD) or hematopoietically active dose (HAD) has been determined. The MTD is defined as the dose prior to the dose level at which at least 2 of the same dose limiting toxicities occur in different patients. Consolidation Phase: Patients then receive consolidation chemotherapy consisting of cytarabine IV over 1 hour every 12 hours (patients 70 years and under) or every 24 hours (patients over 70 years) on days 1-6. Beginning 24-48 hours after completion of consolidation chemotherapy, patients receive leridistim as above. Randomized Phase: Eligible patients will receive induction and consolidation chemotherapy as outlined above. Then patients are randomized to one of two treatments. Arm I: Patients receive leridistim SQ every other day for up to 42 days or until blood counts recover. Arm II: Patients receive filgrastim (G-CSF) SQ daily for up to 42 days or until blood counts recover. Patients are followed at day 30 and then at 6 and 12 months.
PROJECTED ACCRUAL: A total of 86 patients (36 for phase I and 50 for phase II) will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 55 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 |
|---|---|---|
| filgrastim | Biological | – |
| leridistim | Biological | – |
| cytarabine | Drug | – |
| daunorubicin hydrochloride | Drug | – |
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 19 Jun 2013.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Mark Lawrence Heaney, MD, PhD study chair
Memorial Sloan Kettering 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 filgrastim, leridistim and cytarabine in people with Anemia and Leukemia, run by Memorial Sloan Kettering Cancer Center 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 19 Jun 2013. 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?
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 19 Jun 2013.