December 2013

Hematologic Malignancies Clinical Trials

Dear Colleague,

In this edition of our Hematologic Malignancies Clinical Trials Newsletter, we want to highlight five clinical trials using innovative drugs and therapeutic strategies. We hope you find this information useful.

If you want more information on these and other Hematologic Malignancy trials available at the UH Seidman Cancer Center, please feel free to contact us directly.

We wish you a happy holiday season,
Paolo F. Caimi, MD ()
Marcos de Lima, MD ()

Brentuximab Plus Bendamustine For Hodgkin Lymphoma In First Relapse

SEGE 1412. This trial is testing the combination of Brentuximab and Bendamustine for second line therapy for Hodgkin Lymphoma. Eligible patients are those who have failed or relapsed after first line therapy. Patients may proceed to autologous stem cell transplantation within the trial and then continue to receive maintenance Brentuximab.

For more information, contact the Principal Investigator:
Paolo Caimi, MD at

Oral Azacytidine For Myeloid Malignancies

Azacytidine has demonstrated activity against myeloid malignancies. An oral formulation allows for outpatient administration of lower doses over a more prolonged schedule.

CLGN 1912. Oral azacytidine vs. best supportive care for Acute Myeloid Leukemia (AML) in First Remission. This trial is testing the benefit of maintenance with oral Azacytidine in patients 55 years or older with AML in first remission after chemotherapy.

For more information contact:
Brenda Cooper, MD at .

CLGN1Z12. Oral Azacytidine vs. placebo for treatment of transfusion dependent low – risk Myelodysplastic Syndromes (MDS). This trial is testing the use of oral Azacytidine for the treatment of transfusion – dependent MDS patients with low – risk IPSS score.

Basem William, MD, MRCP, the lead investigator, is available to answer any questions through email – .

Ex Vivo Umbilical Cord Blood Expansion With Human Mesenchymal Stem Cells (MSCs)

MESO1Z12. Umbilical cord blood transplantation of ex vivo MSC-expanded UCB. Umbilical cord blood transplantation extends the possibility of hematopoietic stem cell transplantation to patients without fully matched related or unrelated donors. Cell dose is a limitation when transplanting adults. ex vivo expanded UCB in a liquid culture system with mesenchymal stromal cells led to faster engraftment in a phase II study. Here, patients are randomized to receive a double CB transplant in which one unit is ex vivo expanded, versus double unmanipulated CB transplant.

Eligible patients include those with hematologic malignancies (AML, ALL , Hodgkin’s and high risk Non Hodgkin Lymphoma), younger than 65 years of age for whom umbilical cord transplant is planned.

For further information contact our Principal Investigators:
Marcos de Lima at and
Hillard Lazarus at .

Differentiation Therapy For Acute Myeloid Leukemia

CASE 3912. Phase I Trial of Lithium and Tretinoin for Treatment of Non-Promyelocytic Acute Myeloid Leukemia in Patients Intolerant or Relapsed/Refractory to Standard Chemotherapy. This phase I study is investigating the safety of the combination of Lithium and ATRA for the treatment of Acute Myeloid Leukemia.

For more information contact: Paolo Caimi at .

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U.S. News & World Report Best Hospitals 2013-2014 Honor Roll - CancerU.S. News & World Report Best Hospitals 2013-2014 Honor Roll

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