What this study is
This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
What's being tested
- Bortezomib
Intervention · DRUG
- Clofarabine
Intervention · DRUG
- Cyclophosphamide
Intervention · DRUG
- Dexamethasone
Intervention · DRUG
Given IV or PO
- Etoposide
Intervention · DRUG
- Ofatumumab
Intervention · BIOLOGICAL
- Pegfilgrastim
Intervention · BIOLOGICAL
- Rituximab
Intervention · BIOLOGICAL
- Vincristine Sulfate Liposome
Intervention · DRUG
Both Bortezomib and Pegfilgrastim
Given SC
All of Clofarabine, Cyclophosphamide, Etoposide, Ofatumumab, Rituximab, Vincristine Sulfate Liposome
Given IV
Study details
- Official title
- Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Recurrent Acute Lymphoblastic Leukemia · Recurrent Adult Lymphoblastic Lymphoma · Recurrent Burkitt Leukemia · Recurrent Burkitt Lymphoma · Recurrent Childhood Lymphoblastic Lymphoma · Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements · Refractory Acute Lymphoblastic Leukemia · Refractory Burkitt Leukemia · Refractory Burkitt Lymphoma · Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements · Refractory Lymphoblastic Lymphoma
- Enrolling
- 42 people
- Starts
- 2017-08-09
- Est. completion
- 2027-08-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 15 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):; Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II); Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or "double-hit" leukemia/lymphoma (phase II only)
- At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset
- Age older than 15 years
- Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (There may be certain patients with performance status [PS] 3 in the context of rapidly proliferative/refractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)
- Serum bilirubin =< 1.5 mg/dL
- Serum glutamate pyruvate transaminase (SGPT) =< 3 x upper limit normal (ULN), with exception for Gilbert's syndrome
- Estimated creatinine clearance or GFR (glomerular filtration rate) >= 50 mL/min
- Signed informed consent
You can't join if
- Active >= grade 3 peripheral neuropathy
- Active hepatic graft-versus-host disease
- Known positivity for hepatitis B or C
- Pregnancy
- Breast feeding
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openM D Anderson Cancer Center
Houston, Texas, United States
- Maro Ohanian · Contact713-745-0394MOhanian@mdanderson.org
- Maro Ohanian · Principal investigator
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2016-0211
Principal investigator
Maro Ohanian
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.