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RecruitingLast updated: 2 February 2024

NHL33: This phase II trial is assessing the safety and effectiveness of using targeted therapy and chemotherapy to treat fit patients with previously untreated mantle cell lymphoma, with or without a stem cell transplant and further maintenance therapyAn Australasian Leukaemia & Lymphoma Group (ALLG) Window study of Acalbrutinib plus Rituximab (Mabthera) followed by Cytarabine, Oxalipatin, Dexamethasone & Rituximab ( R-DHAOx) + Autologous Stem cell Transplant (ASCT) in fit Mantle Cell Lymphoma

Clinical summary

Summary

All eligible patients will receive Rituximab and Acalabrutinib, followed by 4 cycles of R-DHAOx chemotherapy at trial commencement. Patients who demonstrate at least a partial response to R-DHAOx, will go on to receive BEAM Autologous stem cell transplant in the consolidation phase of the trial, followed by maintenance therapy with Acalabrutinib and Rituximab. Patients who show less than partial response to R-DHAOx will be taken off study and treated as per the local treatment guidelines. The response will be determined by review of a PET/CT scan taken after the patient has completed 4 cycles of R-DHAOx.

Conditions

This trial is treating patients with mantle cell lymphoma

Cancer

Blood Cancers Haematological

Age

People18 - 65

Phase

II

Trial Acronym

NHL33

More information

Trial Identifiers

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Trial sponsor

Acerta Pharma BV,Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific Title

An Australasian Leukaemia & Lymphoma Group (ALLG) Window study of Acalbrutinib plus Rituximab (Mabthera) followed by Cytarabine, Oxalipatin, Dexamethasone & Rituximab ( R-DHAOx) + Autologous Stem cell Transplant (ASCT) in fit Mantle Cell Lymphoma

Eligibility

Inclusion

 

1. Age 18 – 70 years
2. Histologically confirmed diagnosis of CD20 positive mantle cell lymphoma (MCL)
3. No prior lymphoma treatment including chemotherapy, radiotherapy or other investigational drug
4. Stage II-IV disease by Ann Arbor Criteria. Patients with stage I disease with bulk (greater than 7cms) that require systemic treatment will also be eligible. (must be able to undergo PET/CT imaging for staging purposes).
5. PET/CT avid disease at baseline.
6. Eastern Collaborative Oncology Group (ECOG) performance status 0, or 1, unless attributable to lymphoma in which case patients of performance status 2 are also eligible.
7. Adequate bone marrow function with haemoglobin greater than 80g/L, neutrophils greater than 1.0x109/L and platelets greater than 80x109/L at the time of study entry unless attributed to bone marrow infiltration by lymphoma.
8. Adequate renal function defined by an estimated creatinine clearance greater than or equal to 40 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
9. Adequate hepatic function defined by a total bilirubin level less than or equal to 2 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels less than or equal to 3 × upper limit of institutional normal range unless attributed to lymphoma or Gilbert’s syndrome.
10. Patients must have an acceptable left ventricular ejection fraction (LVEF) i.e. within the local normal range for gated heart pool scan or echocardiogram
11. Life expectancy greater than 3 months.
12. Negative blood pregnancy test at screening for women of childbearing potential.
13. Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management.

Exclusion

1. Any lymphoma not fulfilling the WHO diagnostic criteria1 for mantle cell lymphoma
2. Central nervous system involvement including meningeal involvement or cord compression from lymphoma
3. Subjects aged less than 18 or more than 70 years at screening
4. Subjects that are deemed not suitable for autologous stem cell transplant, in the opinion of the treating physician, at time of screening.
5. Subjects with a contraindication to study treatments
6. Prior organ transplantation, including allogeneic stem-cell transplantation
7. Prior malignancy, active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
8. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the subject has not fully recovered from the surgery within 4 weeks of enrolment
9. Past history of interstitial lung disease.
10. Any other serious active disease
11. Presence of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Only patients who are HBV surface antigen (HBVsAg) and/or HBV core antibody (HBVcAb) positive are required to undergo HBV DNA PCR testing. Subjects that are HBV DNA negative who are HBVcAb positive are permitted in the study but must be on HBV prophylaxis.
12. Live vaccines within 30 days prior to the first dose of study drug and while participating in the study.
13. Uncontrolled AIHA (autoimmune hemolytic anaemia) or ITP (idiopathic thrombocytopenia pupura).
14. Suspicion of or confirmed progressive multifocal leukoencephalopathy
15. Has difficulty with or is unable to swallow oral medication, or significant gastrointestinal disease that would limit absorption of oral medication
16. Pregnant or lactating

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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