Clinical trial · Interventional
Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Phase III Study Of Gemcitabine, Dexamethasone, And Cisplatin Compared To Dexamethasone, Cytarabine, And Cisplatin Plus/Minus Rituximab [(R)-GDP vs (R)-DHAP] As Salvage Chemotherapy For Patients With Relapsed Or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior To Autologous Stem Cell Transplant And Followed By Maintenance Rituximab vs Observation
- 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)
RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving rituximab as maintenance therapy after stem cell transplantation may kill any remaining cancer cells. It is not yet known which salvage chemotherapy regimen is more effective before autologous stem cell transplantation in treating relapsed or refractory non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying salvage chemotherapy using dexamethasone, cisplatin, and gemcitabine to see how well it works compared to dexamethasone, cisplatin, and cytarabine given before autologous stem cell transplantation in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. This trial also is studying giving rituximab as maintenance therapy to see how well it works compared to no further therapy after stem cell transplantation. Rituximab was added to both salvage treatment arms for CD20+ patients in a protocol amendment in 2005.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Salvage arm I
- description
- Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.
- interventionNames
- Drug: cisplatin
- Drug: dexamethasone
- Drug: gemcitabine hydrochloride
- type
- EXPERIMENTAL
- label
- Salvage arm II
- description
- Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.
- interventionNames
- Drug: cisplatin
- Drug: cytarabine
- Drug: dexamethasone
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
* Diffuse large cell lymphoma (includes primary mediastinal B-cell lymphoma and T-cell-rich B-cell lymphoma)
* Prior indolent lymphoma (e.g., follicular center cell lymphoma; marginal zone lymphoma, including extranodal mucosa-associated lymphoid tissue \[MALT\] lymphoma; and lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at relapse
* Must be histologically confirmed
* No transformed lymphoma at diagnosis with subsequent indolent histology without transformation at relapse
* Peripheral T-cell lymphoma
* Anaplastic large cell lymphoma
* Small noncleaved Burkitt-like lymphoma
* T-cell or B-cell lineage confirmed by immunohistochemistry
* Clinically or radiologically documented disease meeting either of the following criteria:
* Measurable disease, defined as at least 1 bidimensionally measurable site of disease using clinical exam, CT scan, or MRI
* Lymph nodes must be \> 1.5 cm by physical exam or CT scan
* Other non-nodal lesions must be ≥ 1.0 cm by physical exam, CT scan, or MRI
* Bone lesions are not considered measurable
* Evaluable disease, defined as only nonmeasurable disease, including any of the following:
* Marrow infiltration
* Cytology-confirmed ascites or effusions
* Bony involvement
* Enlarged liver or spleen
* Unidimensionally measurable intrathoracic or abdominal masses
* Previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, and gemcitabine
* No uncontrolled CNS involvement by lymphoma
* No CNS disease at time of relapse
* CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained
PATIENT CHARACTERISTICS:
Age
* 16 to 65
Performance status
* ECOG 0-3
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute granulocyte count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma)
* Hepatitis B status known (for patients with a history of hepatitis B or who are at high risk of hepatitis B infection)
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No significant cardiac dysfunction or cardiovascular disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to complete quality of life questionnaires
* HIV negative
* No active, uncontrolled bacterial, fungal, or viral infection
* No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* No other concurrent serious illness or medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Chemotherapy
* Prior rituximab allowed
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior IV chemotherapy
* No prior high-dose chemotherapy with stem cell transplantation
Endocrine therapy
* No concurrent corticosteroids except for physiologic replacement
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
* Exceptions may be made for low-dose, non-myelosuppressive radiotherapy
* No prior radiotherapy to more than 25% of functioning bone marrow
* Involved-field radiotherapy may be given to areas of bulky disease at relapse (≥ 5 cm) after stem cell transplantation, according to the center's policy
Surgery
* At least 2 weeks since prior major surgery
Other
* No other concurrent anticancer therapy
* No other concurrent experimental agentsReferences
Publications (7)
- BACKGROUNDGupta A, Hay AE, Crump M, Djurfeldt MS, Zhu L, Cheung MC, Shepherd LE, Chen BE, Booth CM. Contact Days Associated With Cancer Treatments in the CCTG LY.12 Trial. Oncologist. 2023 Sep 7;28(9):799-803. doi: 10.1093/oncolo/oyad128. PMID 37226534
- RESULTCrump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. doi: 10.1200/JCO.2013.53.9593. Epub 2014 Sep 29. PMID 25267740
- DERIVEDGupta A, Thomas T, Hay AE, Crump M, Djurfeldt MS, Cheung MC, Prica A, Shepherd LE, Chen BE, Booth CM. The association of health care contact days with economic measures in the CCTG LY.12 trial. Oncologist. 2025 Jun 4;30(6):oyaf165. doi: 10.1093/oncolo/oyaf165. PMID 40503814
- DERIVEDAssouline S, Li S, Gisselbrecht C, Fogarty P, Hay A, van den Neste E, Shepherd LE, Schmitz N, Baetz T, Keating A, Robinson S, Seftel M, Stelitano C, Djurfeldt MS, Meyer R, Chen BE, Crump M. The conditional survival analysis of relapsed DLBCL after autologous transplant: a subgroup analysis of LY.12 and CORAL. Blood Adv. 2020 May 12;4(9):2011-2017. doi: 10.1182/bloodadvances.2020001646. PMID 32396614
- DERIVEDBosch M, Akhter A, Chen BE, Mansoor A, Lebrun D, Good D, Crump M, Shepherd L, Scott DW, Stewart DA. A bioclinical prognostic model using MYC and BCL2 predicts outcome in relapsed/refractory diffuse large B-cell lymphoma. Haematologica. 2018 Feb;103(2):288-296. doi: 10.3324/haematol.2017.179309. Epub 2017 Nov 2. PMID 29097500
- DERIVEDDavison K, Chen BE, Kukreti V, Couban S, Benger A, Berinstein NL, Kaizer L, Desjardins P, Mangel J, Zhu L, Djurfeldt MS, Hay AE, Shepherd LE, Crump M. Treatment outcomes for older patients with relapsed/refractory aggressive lymphoma receiving salvage chemotherapy and autologous stem cell transplantation are similar to younger patients: a subgroup analysis from the phase III CCTG LY.12 trial. Ann Oncol. 2017 Mar 1;28(3):622-627. doi: 10.1093/annonc/mdw653.