RightFit
RecruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
15 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase II study tests the side effects and how well a mix of chemotherapy drugs works. It is for people older than 15 with certain blood or immune system cancers that have come back or have not responded to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or has not responded to treatment.
  • Philadelphia-negative ALL or lymphoblastic lymphoma can enter the early part or phase II. Philadelphia-positive ALL, Burkitt cancer, and double-hit cancer can enter phase II only. Philadelphia status refers to a gene change in cancer cells.
  • Usually, wait at least 21 days after chemotherapy that treats the whole body. This may be 14 days if the cancer is growing fast and there are no major lasting side effects outside the bone marrow.
  • Hydroxyurea and dexamethasone may be used until about 24 hours before study treatment. People with Philadelphia-positive ALL do not need to stop tyrosine kinase inhibitors, a type of targeted drug.
  • Be older than 15 and have an ECOG daily activity score of 3 or less. A score of 3 means needing help with self-care and spending much of the day in bed or a chair.
  • Have liver blood tests within these limits: bilirubin at or below 1.5 mg/dL and SGPT at or below 3 times the upper normal limit. There is an exception for Gilbert's syndrome.
  • Have a kidney filtering test result of at least 50 mL/min.
  • Sign a form agreeing to join after learning about the study.

Who can't join

  • Have severe active nerve damage, called peripheral neuropathy, rated grade 3 or higher.
  • Have active graft-versus-host disease in the liver, where donated immune cells attack the liver.
  • Have a known positive test for hepatitis B or C.
  • Are pregnant.
  • Are breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

TX