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Temozolomide, etoposide, doxil, dexamethasone, and rituximab without ibrutinib (TEDD-R) or TEDD-R with ibrutinib (TEDDI-R), concurrent with cytarabine and isavuconazole, based upon response to 14-day ibrutinib window

Temozolomide, etoposide, doxil, dexamethasone, and rituximab without ibrutinib (TEDD-R) or TEDD-R with ibrutinib Days 1-10 (TEDDI-R), concurrent with cytarabine and isavuconazole, based upon response to 14-day ibrutinib window

Temozolomide, etoposide, doxil, dexamthasone, and rituximab (TEDD-R) given every 21 days for cycles 1-4

TEDD-R

Temozolomide, etoposide, doxil, dexamthasone, ibrutinib and rituximab (TEDDI-R) given every 21 days for cycles 1-4

TEDDI-R

For Arm 1:Ibrutinib given on days -14 to day -1 prior to cycle 1;then given every 21 days for cycles 1-4 For Arm 2: Ibrutinib given on days -14 to day -1 prior to cycle 1; then on days 1-10 for cycles 1-4

Cytarabine on days 1 and day 5 of cycles 2-5 (all arms), as applicable

Isavuconazole to begin at least 3 days prior to ibrutinib and continue throughout chemotherapy unless ibrutinib discontinued permanently

Methotrexate on days 1 and day 5 of cycles 2-5 (all arms), as applicable

Mark J Roschewski, M.D.

Background:

Secondary central nervous system lymphoma (sCNSL) is cancer that has spread to the central nervous system. Most drugs used to treat it do not cross the blood-brain barrier. This makes it hard to treat. Researchers hope that a new combination of drugs may be able to help.

Objective:

To find a better way to treat sCNSL.

Eligibility:

People ages 18 and older with sCNSL

Design:

Participants will be screened with:

* Medical history
* Physical exam
* Blood, urine, and heart tests
* Eye exam
* Tissue or tumor biopsy
* Collection of cerebrospinal fluid
* CT, PET, and MRI scans: Participants will like in a machine that takes pictures of the body.
* Bone marrow aspirations or biopsies: A needle will be inserted into the participant s hipbone. The needle will remove a small amount of marrow.

Participants will take the study drugs in 21-day cycles. They will take some drugs by mouth. They will take others through a catheter: A small tube will be inserted into a vein in the arm, neck, or chest. They may have drugs given through a catheter placed through the brain or injected into the spinal canal.

Participants will have regular visits during the study. These will include repeats of the screening test. They may also provide a saliva sample or have a cheek swab.

Participants will have up to 4 treatment cycles.

Participants will have a follow-up visit 30 days after their last treatment dose. Then they will have visits every 3-6 months for 3 years and then yearly....

Background:

* Aggressive B-cell lymphomas with secondary involvement of the CNS (sCNSL) have a grave prognosis
* No standard of care exists for sCNSL; treatment approaches include combination chemotherapy regimens effective in primary CNS lymphoma (PCNSL)
* Ibrutinib is an inhibitor of Bruton s tyrosine kinase (BTK) and has demonstrated a high response rate in PCNSL and sCNSL but with short response duration
* We developed a novel regimen that combines ibrutinib with a chemoimmunotherapy platform maximized for CNS penetrance that includes temozolomide, etoposide, Doxil, dexamethasone, and rituximab (TEDDI-R) for aggressive B-cell lymphomas in the CNS
* A phase 1 study of TEDDI-R demonstrated durable remissions in refractory PCNSL
* We propose a small phase 2 to study the safety and efficacy of TEDDI-R in sCNSL

Objective:

-To estimate the progression-free survival (PFS) after TEDDI-R or TEDD-R in secondary CNS lymphoma (sCNSL)

Eligibility:

* Aggressive B-cell lymphomas with secondary involvement of the CNS (sCNSL)
* Relapsed/refractory from prior therapy or untreated with CNS involvement
* Age greater than or equal to 18 years
* No pregnant or breast-feeding women.
* Adequate organ function (defined in protocol)

Design:

* Phase II study of 58 evaluable participants with untreated and relapsed/refractory sCNSL (accrual ceiling will be set at 65 to allow for a few possible inevaluable participants and screen fails)
* Participants will first be treated with a 14-day "window" of ibrutinib monotherapy in combination with isavuconazole to establish efficacy of ibrutinib. Participants who are known refractory to BTK inhibitors will skip the 14-day and proceed on to chemotherapy.
* Following the 14-day ibrutinib window, participants with at least a 20% reduction in bidimensional masses on imaging scans or those without measurable disease will receive ibrutinib with TEDD-R (TEDDI-R) chemotherapy for 4 cycles. Participants who are previously known to be refractory to BTK inhibitors and those who have less than a 20% reduction during the ibrutinib window will receive TEDD-R (without ibrutinib) for 4 cycles.

Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)

A Study of Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition all large scale genomic sequencing data will be shared with subscribers to dbGaP.

time from study enrollment until disease progression or death from any cause by arm

the proportion of patients with adverse events leading to discontinuation of therapy

proportion of patients who achieve at least a partial response (PR) to therapy

time from first documentation of tumor response to disease progression

time from study enrollment until disease progression or death from any cause

time from study enrollment until death from any cause

the proportion of patients with adverse events leading to discontinuation of therapy between arms

National Cancer Institute (NCI)

Acalabrutinib

AstraZeneca Clinical Trials

To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).

Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

An Open-label, Phase 1b Study of ACP 196 in Subjects With Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

htttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.

To Characterize the Pharmacokinetic parameter AUC of acalabrutinib

To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib

To evaluate the concentration pharmacodynamic effects of acalabrutinib

To evaluate the activity of acalabrutinib as measured by ORR

Acerta Pharma BV

Acalabrutinib 100mg administered orally (PO) twice daily

Cohort 1 - Relapse Subjects

Cohort 2 - Refractory Subjects

Acalabrutinib 100mg administered orally (PO) twice daily (BID)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)	NCT03964090	Central Nervous... Secondary Centr...	TEDD-R TEDDI-R Ibrutinib Cytarabine Isavuconazole Methotrexate	18 Years -	National Institutes of Health Clinical Center (CC)
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma	NCT02112526	Activated B-cel...	Acalabrutinib	18 Years - 130 Years	Acerta Pharma BV
Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)	NCT03964090	Central Nervous... Secondary Centr...	TEDD-R TEDDI-R Ibrutinib Cytarabine Isavuconazole Methotrexate	18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for abc dlbcl

Every month we try and update this database with for abc dlbcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for abc dlbcl

Every month we try and update this database with for abc dlbcl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for abc dlbcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.