Refractory TdT-Positive LeukemiaPhase 1/2NCT00709215
Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
A Phase 1/2 study testing Cordycepin plus Pentostatin in people with Refractory TdT-Positive Leukemia, run by OncoVista, Inc. at 3 sites in United States.
Trial summary
This is a two-part, open-label, Phase I/II study in subjects with relapsed or refractory TdT-positive leukemia for which no standard therapies are expected to result in durable remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory TdT-Positive Leukemia
- What is being tested?
- Cordycepin plus Pentostatin
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Dec 2010
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TdT-positive leukemia (ALL, AML, or blastic CML) that has failed at least one standard treatment regimen and for which no standard therapies are expected to result in durable remission. Leukemia is minimally defined as at least 20% blast cells present in marrow or peripheral blood. TdT must be expressed in at least 20% of blast cells present and documented either immunologically or biochemically;
- Age ≥18 years;
- Must understand and voluntarily sign informed consent;
- Adequate non-hematologic organ system function, defined by:
- Creatinine ≤1.5 times the upper limit of normal (ULN) and/or creatinine clearance ≥60 mL/min
- AST and/or ALT ≤2.5 times upper limit of normal (ULN)
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- Total bilirubin within institutional normal range
- Normal EKG and LVEF >40%, measured by EKG and MUGA scan, radionuclide ventriculogram, or echocardiogram
- Life expectancy >3 months;
- Performance status (PS) >70% Karnofsky or ECOG ≤2;
- Women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study drug. A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months);
- Male or female of child-bearing potential must agree to use adequate contraceptive methods
Who cannot join
- Failure to meet inclusion criteria;
- Uncontrolled active infection;
- Extramedullary (CNS) disease;
- Serious concomitant medical illness, such as active infection, uncontrolled congestive heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric illness;
- Pregnancy or lactation; females of child bearing potential must use adequate contraceptive methods;
- Less than 3 weeks since prior chemotherapy, radiation therapy, or immunotherapy. However, hydroxyurea is permitted up to 24 hours before the study is initiated;
- Less than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (DLI).
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Daniel J DeAngelo, MD, PhD., 617-632-2645, Daniel_Deangelo@dfci.harvard.edu
Daneil J DeAngelo, MD, PhD.
- Recruiting
Cancer Therapy Reasearch Center at UTHSCA
San Antonio, Texas, 78229
Swaminathan Padmanabhan, MD, 210-450-5094, PadmanabhanS@uthscsa.edu
Monica Mita, MD
About this study
Official title: A Phase I/II Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
This is a two-part, open-label, Phase I/II study in subjects with relapsed or refractory TdT-positive leukemia for which no standard therapies are expected to result in durable remission.
Read the detailed description
In the first phase the Study Objectives are to:
- Define the maximally tolerated dose (MTD) and recommended dose (RD) for administration of cordycepin as a 1-hour IV infusion, administered 1 hour following administration of an IV bolus of pentostatin, in subjects with refractory TdT-positive leukemia;
- Determine plasma ADA levels prior to pentostatin infusion and at 60 and 120 minutes after administration of pentostatin;
- Determine the single and multiple dose pharmacokinetics (PK) of cordycepin given 1 hour after a fixed dose of pentostatin;
- Assess cordycepin pharmacodynamics by measurement of blast cell apoptosis from peripheral blood smears;
- Measure and quantitate any clinical responses in refractory TdT-positive leukemia patients following cordycepin/pentostatin administration.
In the second phase, the Study Objectives are to assess the safety, PK, and clinical outcomes of cordycepin in combination with pentostatin, at the RD, in a 20 subject cohort
- Conditions
- Refractory TdT-Positive Leukemia
- Being tested
- Cordycepin plus Pentostatin
- Keywords
- refractory TdT-positive leukemia, ALL, AML, blastic CML
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordycepin plus PentostatinDrug
Cordycepin Plus Pentostatin on days 1, 2 and 3 of a 21 day cycle. Number of cycles until progression or unacceptable toxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of the recommended dose (RD) of cordycepin, given one hour following a fixed dose of the ADA inhibitor pentostatin, in subjects with refractory TdT-positive leukemia
Measured: one year
Secondary outcomes (1)
Determination of the single and multiple dose pharmacokinetics of cordycepin. Measurement and quantification any any clinical responses following administration of cordycepin/pentostatin at the recomme
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory TdT-Positive 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoVista, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AAIPharma
- Investigators
- Swaminathan Padmanabhan, MD, Principal investigator, Cancer Therapy Research Center at UTHSCSADaneil J DeAngelo, MD, PhD., Principal investigator, Dana Farber Cancr Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709215
- Sponsor's protocol ID
- OV06-001
- Status last verified
- Jan 2009
- First submitted
- 30 Jun 2008
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Verma AK. Cordycepin: a bioactive metabolite of Cordyceps militaris and polyadenylation inhibitor with therapeutic potential against COVID-19. J Biomol Struct Dyn. 2022 May;40(8):3745-3752. doi: 10.1080/07391102.2020.1850352. Epub 2020 Nov 23.
PubMed 33225826
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
- ClinicalTrials.gov ID
- NCT00709215
- Acronym / sponsor ID
- OV06-001
- Conditions
- Refractory TdT-Positive Leukemia
- Keywords
- refractory TdT-positive leukemia, ALL, AML, blastic CML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- OncoVista, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AAIPharma
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 3 Jul 2008 (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.
This is a two-part, open-label, Phase I/II study in subjects with relapsed or refractory TdT-positive leukemia for which no standard therapies are expected to result in durable remission.
Detailed description
In the first phase the Study Objectives are to:
- Define the maximally tolerated dose (MTD) and recommended dose (RD) for administration of cordycepin as a 1-hour IV infusion, administered 1 hour following administration of an IV bolus of pentostatin, in subjects with refractory TdT-positive leukemia;
- Determine plasma ADA levels prior to pentostatin infusion and at 60 and 120 minutes after administration of pentostatin;
- Determine the single and multiple dose pharmacokinetics (PK) of cordycepin given 1 hour after a fixed dose of pentostatin;
- Assess cordycepin pharmacodynamics by measurement of blast cell apoptosis from peripheral blood smears;
- Measure and quantitate any clinical responses in refractory TdT-positive leukemia patients following cordycepin/pentostatin administration.
In the second phase, the Study Objectives are to assess the safety, PK, and clinical outcomes of cordycepin in combination with pentostatin, at the RD, in a 20 subject cohort
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- TdT-positive leukemia (ALL, AML, or blastic CML) that has failed at least one standard treatment regimen and for which no standard therapies are expected to result in durable remission. Leukemia is minimally defined as at least 20% blast cells present in marrow or peripheral blood. TdT must be expressed in at least 20% of blast cells present and documented either immunologically or biochemically;
- Age ≥18 years;
- Must understand and voluntarily sign informed consent;
- Adequate non-hematologic organ system function, defined by:
- Life expectancy >3 months;
Key exclusion criteria (7 listed)
- Failure to meet inclusion criteria;
- Uncontrolled active infection;
- Extramedullary (CNS) disease;
- Serious concomitant medical illness, such as active infection, uncontrolled congestive heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric illness;
- Pregnancy or lactation; females of child bearing potential must use adequate contraceptive methods;
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 |
|---|---|---|
| Cordycepin plus PentostatinCordycepin Plus Pentostatin on days 1, 2 and 3 of a 21 day cycle. Number of cycles until progression or unacceptable toxicity | Drug | – |
Primary outcome
Establishment of the recommended dose (RD) of cordycepin, given one hour following a fixed dose of the ADA inhibitor pentostatin, in subjects with refractory TdT-positive leukemia
Time frame: one year
1 secondary outcome
Determination of the single and multiple dose pharmacokinetics of cordycepin. Measurement and quantification any any clinical responses following administration of cordycepin/pentostatin at the recomme
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2009.
- Derived from this study: PubMed 33225826Verma AK. Cordycepin: a bioactive metabolite of Cordyceps militaris and polyadenylation inhibitor with therapeutic potential against COVID-19. J Biomol Struct Dyn. 2022 May;40(8):3745-3752. doi: 10.1080/07391102.2020.1850352. Epub 2020 Nov 23.
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.
Swaminathan Padmanabhan, MD principal investigator
Cancer Therapy Research Center at UTHSCSA
Daneil J DeAngelo, MD, PhD. principal investigator
Dana Farber Cancr Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cordycepin plus Pentostatin in people with Refractory TdT-Positive Leukemia, run by OncoVista, Inc. at 3 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 12 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Jan 2009. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Moloney, MBA, BS (210.677.6000 ext. 201, michael.moloney@oncovista.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of the recommended dose (RD) of cordycepin, given one hour following a fixed dose of the ADA inhibitor pentostatin, in subjects with refractory TdT-positive leukemia (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709215, which also lists 1 linked publication.
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 9 Jan 2009.