Status:
COMPLETED
Clinical Trial of BP1001 (L-Grb-2 Antisense Oligonucleotide) in CML, AML, ALL & MDS
Lead Sponsor:
Bio-Path Holdings, Inc.
Conditions:
Recurrent Adult Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The first goal of this clinical research study is to find the highest safe dose of BP1001, a liposomal Growth Factor Receptor Bound Protein-2 antisense oligodeoxynucleotide (L-Grb2 AS), for patients w...
Detailed Description
The Philadelphia Chromosome is an unusual genetic trait found in 90-95% of patients with CML and approximately 20-25% of patients with ALL. The protein created by this unusual trait causes normal cell...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female patients 18 years of age or older
- A diagnosis of refractory or relapsed AML, or Ph+ CML (in chronic, accelerated or blast phase, or acute lymphoblastic leukemia, or myelodysplastic syndrome.
- One of the following parameters is required to meet criteria for accelerated phase CML:
- Blasts in Peripheral Blood or Bone Marrow ≥15%
- Promyelocytes and Blasts in Peripheral Blood or Bone Marrow ≥30%
- PB or BM basophils ≥20%
- Thrombocytopenia \<100 x 103/ml, not resulting from therapy
- Blast phase is defined as ≥30% blasts in peripheral blood or bone marrow, or presence of extramedullary disease, except for liver or spleen.
- Patients with CML must have demonstrated resistance and/or intolerance to therapy with at least 2 tyrosine kinase inhibitors (TKI)
- Patients with AML and ALL should have received at least 1 prior treatment regimen and either failed to achieve response or relapsed on treatment
- Patients with MDS should have failed prior therapy with a hypomethylating agent or, if associated with a 5q- chromosomal abnormality, lenalidomide. NOTE: Patients with 5q- unable to receive or intolerant to lenalidomide are also eligible.
- Have clinically adequate hepatic and renal functions as defined by:
- ALT\<2x ULN
- Serum creatinine concentration \<2x ULN
- Serum bilirubin \<2x ULN
- Patients must sign an informed consent
- Women of childbearing age must have a negative serum or urine pregnancy test prior to the initiation of study drug.
- Barrier contraceptive precautions are to be used throughout the trial by all study participants of child bearing potential.
- Have not received anti-cancer therapy for at least 2 weeks prior to study entry, with the exception of low dose ara-C (LDAC) given as subcutaneous injections (no less than 15 days prior), hydroxyurea or anagrelide (no less than 24 hours prior), TKI (no less than 5 days prior), and interferon (no less than 2 weeks prior)
- Have an ECOG Performance of 0-2
- Have a life-expectancy ≥3 months
- Exclusion Criteria
- Serious intercurrent medical illnesses which would interfere with the ability of the patient to carry out the treatment program
- Pregnant or breastfeeding women
- Patients who have uncontrolled active infection
- Patients who have received another investigational product within the longer of 14 days or 5 half-lives of the previous product
- Any history of adverse reaction or hypersensitivity to LDAC
- Part B: BP1001 with Concurrent LDAC Dose-Expansion Cohorts
- Enrollment in the dose-expansion cohorts (DEC) will be limited to only those patients with a diagnosis of refractory or relapsed AML(except acute promyelocytic leukemia) or those who are refractory to at least 1 prior therapy regimen and no more than 1 prior salvage regimen.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01159028
Start Date
June 1 2010
End Date
March 30 2017
Last Update
May 28 2020
Active Locations (1)
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1
M. D. Anderson Cancer Center
Houston, Texas, United States, 77030