LeukemiaPhase 2NCT00483067
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
A Phase 2 study testing 2-CdA, Ara-C and G-CSF (Granulocyte colony-stimulating factor) in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the response rate, progression-free survival (PFS) and overall survival of patients who receive 2-CdA + Ara-C. 2. To examine if there is any clonality in the cytokine expression of helper T cells or cytokine receptor expression of eosinophils. 3. Read more about this study
- Who is it for?
- Ages Up to 76 years
- Conditions the study is for
- Leukemia
- What is being tested?
- 2-CdA, Ara-C and G-CSF (Granulocyte colony-stimulating factor)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1998to Jul 2008
- 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 Up to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must have diagnosis of idiopathic HES, defined as (1) no recent history of allergic reaction or parasitic infection; (2) sustained (> 6 months) hypereosinophilia (1,500/mm^3); and (3) signs or symptoms of organ involvement.
- Age less than 76 years old.
- Patient is not pregnant.
- Zubrod performance status < 3.
- Life expectancy is not severely limited by concomitant illness.
- Serum creatinine < 2 mg/dL.
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- Serum bilirubin < 2 times upper limit of normal (2 mg/dL).
- Alanine aminotransferase (SGPT) < 2 times upper limit of normal (112 IU/L).
- Participant has completed the informed consent process, understands the investigational nature of the study, agrees to participate, and has signed the informed consent.
Who cannot join
- Evidence of chronic active hepatitis or cirrhosis, and > 1 month from prior episode of hepatitis.
- Presence of an active infection.
- HIV positive.
- Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
- Recent history of parasite infection.
- Recent history of allergic reaction.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)
Primary Objectives:
- To determine the response rate, progression-free survival (PFS) and overall survival of patients who receive 2-CdA + Ara-C.
- To examine if there is any clonality in the cytokine expression of helper T cells or cytokine receptor expression of eosinophils.
- To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.
Read the detailed description
Before the study begins, patients will have a physical exam, blood tests, and urine tests. Women will have a pregnancy test. A bone marrow sample will be taken. This is done with a large needle. Heart tests and an MRI scan of the brain will be done if there is a suspicion of disease in the heart or central nervous system.
Patients in this study must have a catheter (thin tube) placed in a vein in the arm or under the collarbone. This tube will be left in place throughout the study. 2-CdA (Cladribine) will be given through the catheter 24 hours a day on days 2 to 6. Ara-C (Cytarabine) will be given through the catheter over 2 hours on days 1, 3, 4, 5, and 6. Starting on day 9, patients will inject G-CSF under their skin once a day; G-CSF helps blood counts return to normal. Treatment will be given on an inpatient or outpatient basis. The first course is normally done inpatient.
During the study, patients will have blood tests daily during the first week and every other day after that. Bone marrow samples will be taken on days 14, 21, and 28. Further bone marrow samples may be necessary to evaluate response. Heart tests and MRI scans of the brain may be done.
This is an investigational study. G-CSF, 2-CdA, and Cytarabine are approved by the FDA for treatment of cancer. Up to 40 patients will take part in this study. Patients will be treated at M. D. Anderson or other centers. A total of 40 people will take part in this study. About 1 patient every 3 months will be enrolled at M. D. Anderson.
- Conditions
- Leukemia
- Being tested
- 2-CdA, Ara-C, G-CSF (Granulocyte colony-stimulating factor)
- Keywords
- Idiopathic Hypereosinophilic Syndrome, Leukemia, 2-Chlorodeoxyadenosine, Cladribine, Cytarabine, Ara-C, 2-CdA, G-CSF, HES
- Medical subject headings
- Leukemia, Hypereosinophilic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-CdADrug
Also called 2-Chlorodeoxyadenosine, Cladribine
12 mg/m^2/day by vein (IV) Continuous Infusion x 5 Days
Ara-CDrug
Also called Cytarabine
1 gm/m^2/day IV Over 2 Hours x 5 Days
G-CSF (Granulocyte colony-stimulating factor)Drug
Also called Filgrastim, Neupogen, Granulocyte colony-stimulating factor, GCSF
5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
| Study group | Role | What they receive |
|---|---|---|
| 2-CdA + Ara-C + G-CSF | Experimental | 2-CdA 12 mg/m^2/day by vein (IV) Continuous Infusion and Ara-C 1 gm/m^2/day IV for 5 Days with G-CSF 5 mcg/kg/day subcutaneously starting Day 9 Receives: Drug: 2-CdA; Drug: Ara-C; Drug: G-CSF (Granulocyte colony-stimulating factor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Outcomes at 6 Weeks
Patient outcomes defined at 6 weeks as Complete Remission (CR), absolute eosinophil count less than 1,500/mm3 and less than 5% of eosinophilic infiltrates in the bone marrow; and PR (partial response) defined as major clinical improvement without meeting the criteria specified for CR including an improvement in performance status to Zubrod's 0 or 1 along with clearance of clinical signs and symptoms of disease that are present at baseline.
Measured: Baseline to 6 weeks timepoint (day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startMar 1998
- Primary completionMar 2006
- Study completionJul 2008
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.
- More trials run by M.D. Anderson 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Andreeff, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483067
- Sponsor's protocol ID
- DM97-232
- Status last verified
- Aug 2012
- First submitted
- 5 Jun 2007
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)
- ClinicalTrials.gov ID
- NCT00483067
- Acronym / sponsor ID
- DM97-232
- Conditions
- Leukemia
- Keywords
- Idiopathic Hypereosinophilic Syndrome, Leukemia, 2-Chlorodeoxyadenosine, Cladribine, Cytarabine, Ara-C, 2-CdA, G-CSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 1998
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Jun 2007 (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.
Primary Objectives:
- To determine the response rate, progression-free survival (PFS) and overall survival of patients who receive 2-CdA + Ara-C.
- To examine if there is any clonality in the cytokine expression of helper T cells or cytokine receptor expression of eosinophils.
- To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.
Detailed description
Before the study begins, patients will have a physical exam, blood tests, and urine tests. Women will have a pregnancy test. A bone marrow sample will be taken. This is done with a large needle. Heart tests and an MRI scan of the brain will be done if there is a suspicion of disease in the heart or central nervous system.
Patients in this study must have a catheter (thin tube) placed in a vein in the arm or under the collarbone. This tube will be left in place throughout the study. 2-CdA (Cladribine) will be given through the catheter 24 hours a day on days 2 to 6. Ara-C (Cytarabine) will be given through the catheter over 2 hours on days 1, 3, 4, 5, and 6. Starting on day 9, patients will inject G-CSF under their skin once a day; G-CSF helps blood counts return to normal. Treatment will be given on an inpatient or outpatient basis. The first course is normally done inpatient.
During the study, patients will have blood tests daily during the first week and every other day after that. Bone marrow samples will be taken on days 14, 21, and 28. Further bone marrow samples may be necessary to evaluate response. Heart tests and MRI scans of the brain may be done.
This is an investigational study. G-CSF, 2-CdA, and Cytarabine are approved by the FDA for treatment of cancer. Up to 40 patients will take part in this study. Patients will be treated at M. D. Anderson or other centers. A total of 40 people will take part in this study. About 1 patient every 3 months will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2-CdA + Ara-C + G-CSF | Experimental | Drug: 2-CdA, Drug: Ara-C, Drug: G-CSF (Granulocyte colony-stimulating factor)2-CdA 12 mg/m^2/day by vein (IV) Continuous Infusion and Ara-C 1 gm/m^2/day IV for 5 Days with G-CSF 5 mcg/kg/day subcutaneously starting Day 9 |
Who may qualify
- Ages
- Up to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must have diagnosis of idiopathic HES, defined as (1) no recent history of allergic reaction or parasitic infection; (2) sustained (> 6 months) hypereosinophilia (1,500/mm^3); and (3) signs or symptoms of organ involvement.
- Age less than 76 years old.
- Patient is not pregnant.
- Zubrod performance status < 3.
- Life expectancy is not severely limited by concomitant illness.
Key exclusion criteria (6 listed)
- Evidence of chronic active hepatitis or cirrhosis, and > 1 month from prior episode of hepatitis.
- Presence of an active infection.
- HIV positive.
- Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
- Recent history of parasite infection.
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 |
|---|---|---|
| 2-CdAAlso: 2-Chlorodeoxyadenosine, Cladribine12 mg/m^2/day by vein (IV) Continuous Infusion x 5 Days | Drug | 2-CdA + Ara-C + G-CSF |
| Ara-CAlso: Cytarabine1 gm/m^2/day IV Over 2 Hours x 5 Days | Drug | 2-CdA + Ara-C + G-CSF |
| G-CSF (Granulocyte colony-stimulating factor)Also: Filgrastim, Neupogen, Granulocyte colony-stimulating factor, GCSF5 mcg/kg/day given under the skin (subcutaneously) starting Day 9 | Drug | 2-CdA + Ara-C + G-CSF |
Primary outcome
Patient Outcomes at 6 Weeks
Time frame: Baseline to 6 weeks timepoint (day 42)
Patient outcomes defined at 6 weeks as Complete Remission (CR), absolute eosinophil count less than 1,500/mm3 and less than 5% of eosinophilic infiltrates in the bone marrow; and PR (partial response) defined as major clinical improvement without meeting the criteria specified for CR including an improvement in performance status to Zubrod's 0 or 1 along with clearance of clinical signs and symptoms of disease that are present at baseline.
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 2 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Michael Andreeff, MD, PhD principal investigator
M.D. Anderson 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 2-CdA, Ara-C and G-CSF (Granulocyte colony-stimulating factor) in people with Leukemia, run by M.D. Anderson 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?
The sponsor lists 9 inclusion and 6 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 2 Aug 2012. 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.
What does the primary outcome measure?
Patient Outcomes at 6 Weeks (time frame: Baseline to 6 weeks timepoint (day 42)). 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 2 Aug 2012.