Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Adult Lymphoblastic Lymphoma | Adult Lymphoblastic Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Burkitt Leukemia | Burkitt Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Burkitt Lymphoma | Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Lymphoblastic Lymphoma | Childhood Lymphoblastic Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | High Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements | CURATED_BROADER | 0.78 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Clofarabine | Drug | Clofarabine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Ofatumumab | Biological | Ofatumumab | ALIAS |
| Pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (combination chemotherapy)
- description
- See detailed description
- interventionNames
- Drug: Bortezomib
- Drug: Clofarabine
- Drug: Cyclophosphamide
- Drug: Dexamethasone
- Drug: Etoposide
- Biological: Ofatumumab
- Biological: Pegfilgrastim
- Biological: Rituximab
- Drug: Vincristine Sulfate Liposome
Primary outcomes (2)
- measure
- Incidence of adverse events
- timeFrame
- Up to 8 years
- description
- The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Active \>= grade 3 peripheral neuropathy * Active hepatic graft-versus-host disease * Known positivity for hepatitis B or C * Pregnancy * Breast feeding
References
Publications (0)
Data not yet available